A Phase 2 interventional study of Multivalent and Prevnar 13 in Pneumococcal Infections, sponsored by Pfizer. Terminated at 48 sites in United States. Open to participants aged 42 Days to 98 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Pfizer · Phase 2, Interventional, and Prevention
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 565 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13
Biological: Multivalent · Biological: Prevnar 13
Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13
Biological: Multivalent · Biological: Prevnar 13
Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine
Biological: Multivalent · Biological: Prevnar 13
Pneumococcal conjugate vaccine
Also known as: Pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time frame: Within 7 Days After Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time frame: Within 7 Days After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time frame: Within 7 Days After Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time frame: Within 7 Days After Dose 4
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time frame: Within 7 Days After Supplemental Dose
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (\>=) 38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
Time frame: Within 7 Days After Supplemental Dose
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time frame: From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)
Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time frame: From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)
Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time frame: From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study
An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Time frame: From Dose 1 to End of the Study (up to duration of 17 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.
Time frame: From Dose 1 to End of the Study (up to duration of 17 months)
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3
IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.
Time frame: 1 Month After Dose 3
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Percentage of participants with pre-specified IgG concentration (\>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.
Time frame: 1 Month after Dose 3
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4
IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.
Time frame: 1 Month After Dose 4
| Milestone | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Started | 192 | 187 | 186 |
| Vaccinated for dose 1 | 171 | 147 | 166 |
| Vaccinated for dose 2 | 159 | 135 | 153 |
| Vaccinated for dose 3 | 151 | 127 | 146 |
| Completed | 95 | 77 | 72 |
| Not completed | 97 | 110 | 114 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 5 | 7 | 12 |
| Withdrew: Study terminated by sponsor | 44 | 37 | 48 |
| Withdrew: No longer met eligibility criteria | 3 | 5 | 6 |
| Withdrew: Withdrawal by parent/guardian | 20 | 18 | 26 |
| Withdrew: Other | 4 | 2 | 2 |
| Withdrew: Randomized but not vaccinated | 3 | 23 | 2 |
| Withdrew: Sites terminated due to quality issues | 18 | 17 | 18 |
Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Redness: Any | 25.9 (19.4 to 33.3) | 26.4 (19.4 to 34.4) | 21.8 (15.8 to 28.9) |
| Redness: Mild | 16.3 (11.0 to 22.8) | 21.5 (15.1 to 29.1) | 18.2 (12.6 to 24.9) |
| Redness: Moderate | 9.6 (5.6 to 15.2) | 4.9 (2.0 to 9.8) | 3.6 (1.3 to 7.7) |
| Redness: Severe | 0 (0.0 to 2.2) | 0 (0.0 to 2.5) | 0 (0.0 to 2.2) |
| Swelling: Any | 27.1 (20.5 to 34.5) | 22.2 (15.7 to 29.9) | 23.6 (17.4 to 30.9) |
| Swelling: Mild | 16.3 (11.0 to 22.8) | 13.9 (8.7 to 20.6) | 17.0 (11.6 to 23.6) |
| Swelling: Moderate | 10.2 (6.1 to 15.9) | 8.3 (4.4 to 14.1) | 5.5 (2.5 to 10.1) |
| Swelling: Severe | 0.6 (0.0 to 3.3) | 0 (0.0 to 2.5) | 1.2 (0.1 to 4.3) |
| Pain at Injection Site: Any | 59.6 (51.8 to 67.2) | 40.3 (32.2 to 48.8) | 50.3 (42.4 to 58.2) |
| Pain at Injection Site: Mild | 28.9 (22.2 to 36.4) | 28.5 (21.3 to 36.6) | 26.1 (19.5 to 33.5) |
| Pain at Injection Site: Moderate | 27.7 (21.1 to 35.2) | 11.1 (6.5 to 17.4) | 22.4 (16.3 to 29.6) |
| Pain at Injection Site: Severe | 3.0 (1.0 to 6.9) | 0.7 (0.0 to 3.8) | 1.8 (0.4 to 5.2) |
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Redness: Any | 28.9 (21.9 to 36.8) | 20.6 (13.9 to 28.8) | 23.8 (17.2 to 31.5) |
| Redness: Mild | 22.4 (16.0 to 29.8) | 18.3 (11.9 to 26.1) | 21.1 (14.8 to 28.6) |
| Redness: Moderate | 6.6 (3.2 to 11.8) | 2.4 (0.5 to 6.8) | 2.7 (0.7 to 6.8) |
| Redness: Severe | 0 (0.0 to 2.4) | 0 (0.0 to 2.9) | 0 (0.0 to 2.5) |
| Swelling: Any | 21.1 (14.9 to 28.4) | 16.7 (10.6 to 24.3) | 22.4 (16.0 to 30.1) |
| Swelling: Mild | 14.5 (9.3 to 21.1) | 14.3 (8.7 to 21.6) | 16.3 (10.7 to 23.3) |
| Swelling: Moderate | 6.6 (3.2 to 11.8) | 2.4 (0.5 to 6.8) | 6.1 (2.8 to 11.3) |
| Swelling: Severe | 0 (0.0 to 2.4) | 0 (0.0 to 2.9) | 0 (0.0 to 2.5) |
| Pain at Injection Site: Any | 55.3 (47.0 to 63.3) | 23.8 (16.7 to 32.2) | 46.9 (38.7 to 55.3) |
| Pain at Injection Site: Mild | 31.6 (24.3 to 39.6) | 19.0 (12.6 to 27.0) | 27.9 (20.8 to 35.9) |
| Pain at Injection Site: Moderate | 21.7 (15.4 to 29.1) | 4.8 (1.8 to 10.1) | 18.4 (12.5 to 25.6) |
| Pain at Injection Site: Severe | 2.0 (0.4 to 5.7) | 0 (0.0 to 2.9) | 0.7 (0.0 to 3.7) |
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Redness: Any | 25.2 (18.3 to 33.1) | 20.0 (13.3 to 28.3) | 22.5 (15.8 to 30.3) |
| Redness: Mild | 23.1 (16.4 to 30.9) | 19.2 (12.6 to 27.4) | 18.1 (12.1 to 25.6) |
| Redness: Moderate | 2.1 (0.4 to 6.0) | 0.8 (0.0 to 4.6) | 4.3 (1.6 to 9.2) |
| Redness: Severe | 0 (0.0 to 2.5) | 0 (0.0 to 3.0) | 0 (0.0 to 2.6) |
| Swelling: Any | 21.7 (15.2 to 29.3) | 14.2 (8.5 to 21.7) | 18.1 (12.1 to 25.6) |
| Swelling: Mild | 17.5 (11.6 to 24.7) | 11.7 (6.5 to 18.8) | 13.8 (8.5 to 20.7) |
| Swelling: Moderate | 4.2 (1.6 to 8.9) | 2.5 (0.5 to 7.1) | 3.6 (1.2 to 8.3) |
| Swelling: Severe | 0 (0.0 to 2.5) | 0 (0.0 to 3.0) | 0.7 (0.0 to 4.0) |
| Pain at Injection Site: Any | 39.9 (31.8 to 48.4) | 22.5 (15.4 to 31.0) | 35.5 (27.6 to 44.1) |
| Pain at Injection Site: Mild | 23.8 (17.1 to 31.6) | 17.5 (11.2 to 25.5) | 18.8 (12.7 to 26.4) |
| Pain at Injection Site: Moderate | 15.4 (9.9 to 22.4) | 5.0 (1.9 to 10.6) | 15.2 (9.7 to 22.3) |
| Pain at Injection Site: Severe | 0.7 (0.0 to 3.8) | 0 (0.0 to 3.0) | 1.4 (0.2 to 5.1) |
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Redness: Any | 22.9 (15.2 to 32.1) | 19.0 (11.0 to 29.4) | 22.4 (14.6 to 32.0) |
| Redness: Mild | 21.9 (14.4 to 31.0) | 15.2 (8.1 to 25.0) | 19.4 (12.1 to 28.6) |
| Redness: Moderate | 1.0 (0.0 to 5.2) | 3.8 (0.8 to 10.7) | 3.1 (0.6 to 8.7) |
| Redness: Severe | 0 (0.0 to 3.5) | 0 (0.0 to 4.6) | 0 (0.0 to 3.7) |
| Swelling: Any | 19.0 (12.0 to 27.9) | 13.9 (7.2 to 23.5) | 19.4 (12.1 to 28.6) |
| Swelling: Mild | 17.1 (10.5 to 25.7) | 8.9 (3.6 to 17.4) | 13.3 (7.3 to 21.6) |
| Swelling: Moderate | 1.9 (0.2 to 6.7) | 5.1 (1.4 to 12.5) | 6.1 (2.3 to 12.9) |
| Swelling: Severe | 0 (0.0 to 3.5) | 0 (0.0 to 4.6) | 0 (0.0 to 3.7) |
| Pain at Injection Site: Any | 35.2 (26.2 to 45.2) | 22.8 (14.1 to 33.6) | 28.6 (19.9 to 38.6) |
| Pain at Injection Site: Mild | 21.9 (14.4 to 31.0) | 16.5 (9.1 to 26.5) | 18.4 (11.3 to 27.5) |
| Pain at Injection Site: Moderate | 12.4 (6.8 to 20.2) | 6.3 (2.1 to 14.2) | 10.2 (5.0 to 18.0) |
| Pain at Injection Site: Severe | 1.0 (0.0 to 5.2) | 0 (0.0 to 4.6) | 0 (0.0 to 3.7) |
Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0.0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
| Percentage of participants | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|
| Redness: Any | 5.9 (1.9 to 13.2) |
| Redness: Mild | 4.7 (1.3 to 11.6) |
| Redness: Moderate | 1.2 (0.0 to 6.4) |
| Redness: Severe | 0 (0.0 to 4.2) |
| Swelling: Any | 9.4 (4.2 to 17.7) |
| Swelling: Mild | 9.4 (4.2 to 17.7) |
| Swelling: Moderate | 0 (0.0 to 4.2) |
| Swelling: Severe | 0 (0.0 to 4.2) |
| Pain at Injection Site: Any | 12.9 (6.6 to 22.0) |
| Pain at Injection Site: Mild | 11.8 (5.8 to 20.6) |
| Pain at Injection Site: Moderate | 1.2 (0.0 to 6.4) |
| Pain at Injection Site: Severe | 0 (0.0 to 4.2) |
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (\>=) 38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Fever: >=38.0 degree C | 12.7 (8.0 to 18.7) | 5.6 (2.4 to 10.7) | 9.1 (5.2 to 14.6) |
| Fever: >=38.0 degree C to 38.4 degree C | 7.8 (4.2 to 13.0) | 3.5 (1.1 to 7.9) | 6.1 (2.9 to 10.9) |
| Fever: >38.4 degree C to 38.9 degree C | 3.0 (1.0 to 6.9) | 0.7 (0.0 to 3.8) | 2.4 (0.7 to 6.1) |
| Fever: >38.9 degree C to 40.0 degree C | 1.8 (0.4 to 5.2) | 1.4 (0.2 to 4.9) | 0.6 (0.0 to 3.3) |
| Fever: >40.0 degree C | 0 (0.0 to 2.2) | 0 (0.0 to 2.5) | 0 (0.0 to 2.2) |
| Decreased Appetite: Any | 28.9 (22.2 to 36.4) | 15.3 (9.8 to 22.2) | 26.7 (20.1 to 34.1) |
| Decreased Appetite: Mild | 19.3 (13.6 to 26.1) | 6.3 (2.9 to 11.5) | 14.5 (9.5 to 20.9) |
| Decreased Appetite: Moderate | 7.2 (3.8 to 12.3) | 9.0 (4.9 to 14.9) | 10.3 (6.1 to 16.0) |
| Decreased Appetite: Severe | 2.4 (0.7 to 6.1) | 0 (0.0 to 2.5) | 1.8 (0.4 to 5.2) |
| Drowsiness: Any | 59.6 (51.8 to 67.2) | 43.1 (34.8 to 51.6) | 53.3 (45.4 to 61.1) |
| Drowsiness: Mild | 41.6 (34.0 to 49.5) | 31.9 (24.4 to 40.2) | 38.2 (30.7 to 46.1) |
| Drowsiness: Moderate | 16.3 (11.0 to 22.8) | 9.7 (5.4 to 15.8) | 13.3 (8.5 to 19.5) |
| Drowsiness: Severe | 1.8 (0.4 to 5.2) | 1.4 (0.2 to 4.9) | 1.8 (0.4 to 5.2) |
| Irritability: Any | 70.5 (62.9 to 77.3) | 57.6 (49.1 to 65.8) | 63.6 (55.8 to 71.0) |
| Irritability: Mild | 25.3 (18.9 to 32.6) | 29.2 (21.9 to 37.3) | 23.6 (17.4 to 30.9) |
| Irritability: Moderate | 38.0 (30.5 to 45.8) | 23.6 (16.9 to 31.4) | 36.4 (29.0 to 44.2) |
| Irritability: Severe | 7.2 (3.8 to 12.3) | 4.9 (2.0 to 9.8) | 3.6 (1.3 to 7.7) |
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Fever: >=38.0 degree C | 25.7 (18.9 to 33.4) | 4.0 (1.3 to 9.0) | 15.6 (10.2 to 22.5) |
| Fever: >=38.0 degree C to 38.4 degree C | 12.5 (7.7 to 18.8) | 3.2 (0.9 to 7.9) | 8.2 (4.3 to 13.8) |
| Fever: >38.4 degree C to 38.9 degree C | 10.5 (6.1 to 16.5) | 0.8 (0.0 to 4.3) | 2.7 (0.7 to 6.8) |
| Fever: >38.9 degree C to 40.0 degree C | 2.6 (0.7 to 6.6) | 0 (0.0 to 2.9) | 4.1 (1.5 to 8.7) |
| Fever: >40.0 degree C | 0 (0.0 to 2.4) | 0 (0.0 to 2.9) | 0.7 (0.0 to 3.7) |
| Decreased Appetite: Any | 23.0 (16.6 to 30.5) | 12.7 (7.4 to 19.8) | 25.2 (18.4 to 33.0) |
| Decreased Appetite: Mild | 11.8 (7.2 to 18.1) | 8.7 (4.4 to 15.1) | 15.6 (10.2 to 22.5) |
| Decreased Appetite: Moderate | 9.9 (5.6 to 15.8) | 4.0 (1.3 to 9.0) | 9.5 (5.3 to 15.5) |
| Decreased Appetite: Severe | 1.3 (0.2 to 4.7) | 0 (0.0 to 2.9) | 0 (0.0 to 2.5) |
| Drowsiness: Any | 48.7 (40.5 to 56.9) | 21.4 (14.6 to 29.6) | 42.9 (34.7 to 51.3) |
| Drowsiness: Mild | 32.2 (24.9 to 40.3) | 15.1 (9.3 to 22.5) | 25.9 (19.0 to 33.7) |
| Drowsiness: Moderate | 15.1 (9.8 to 21.8) | 6.3 (2.8 to 12.1) | 17.0 (11.3 to 24.1) |
| Drowsiness: Severe | 1.3 (0.2 to 4.7) | 0 (0.0 to 2.9) | 0 (0.0 to 2.5) |
| Irritability: Any | 64.5 (56.3 to 72.1) | 44.4 (35.6 to 53.6) | 58.5 (50.1 to 66.6) |
| Irritability: Mild | 20.4 (14.3 to 27.7) | 21.4 (14.6 to 29.6) | 17.7 (11.9 to 24.8) |
| Irritability: Moderate | 40.8 (32.9 to 49.0) | 20.6 (13.9 to 28.8) | 36.1 (28.3 to 44.4) |
| Irritability: Severe | 3.3 (1.1 to 7.5) | 2.4 (0.5 to 6.8) | 4.8 (1.9 to 9.6) |
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Fever: >=38.0 degree C | 14.0 (8.8 to 20.8) | 5.8 (2.4 to 11.6) | 14.5 (9.1 to 21.5) |
| Fever: >=38.0 degree C to 38.4 degree C | 6.3 (2.9 to 11.6) | 3.3 (0.9 to 8.3) | 8.0 (4.0 to 13.8) |
| Fever: >38.4 degree C to 38.9 degree C | 5.6 (2.4 to 10.7) | 1.7 (0.2 to 5.9) | 2.9 (0.8 to 7.3) |
| Fever: >38.9 degree C to 40.0 degree C | 1.4 (0.2 to 5.0) | 0.8 (0.0 to 4.6) | 3.6 (1.2 to 8.3) |
| Fever: >40.0 degree C | 0.7 (0.0 to 3.8) | 0 (0.0 to 3.0) | 0 (0.0 to 2.6) |
| Decreased Appetite: Any | 19.6 (13.4 to 27.0) | 18.3 (11.9 to 26.4) | 21.0 (14.5 to 28.8) |
| Decreased Appetite: Mild | 12.6 (7.6 to 19.2) | 12.5 (7.2 to 19.8) | 10.1 (5.7 to 16.4) |
| Decreased Appetite: Moderate | 7.0 (3.4 to 12.5) | 5.8 (2.4 to 11.6) | 10.1 (5.7 to 16.4) |
| Decreased Appetite: Severe | 0 (0.0 to 2.5) | 0 (0.0 to 3.0) | 0.7 (0.0 to 4.0) |
| Drowsiness: Any | 43.4 (35.1 to 51.9) | 21.7 (14.7 to 30.1) | 45.7 (37.2 to 54.3) |
| Drowsiness: Mild | 29.4 (22.1 to 37.6) | 16.7 (10.5 to 24.6) | 32.6 (24.9 to 41.1) |
| Drowsiness: Moderate | 13.3 (8.2 to 20.0) | 3.3 (0.9 to 8.3) | 12.3 (7.3 to 19.0) |
| Drowsiness: Severe | 0.7 (0.0 to 3.8) | 1.7 (0.2 to 5.9) | 0.7 (0.0 to 4.0) |
| Irritability: Any | 57.3 (48.8 to 65.6) | 50.8 (41.6 to 60.1) | 53.6 (44.9 to 62.1) |
| Irritability: Mild | 25.2 (18.3 to 33.1) | 26.7 (19.0 to 35.5) | 23.9 (17.1 to 31.9) |
| Irritability: Moderate | 31.5 (24.0 to 39.8) | 21.7 (14.7 to 30.1) | 26.8 (19.6 to 35.0) |
| Irritability: Severe | 0.7 (0.0 to 3.8) | 2.5 (0.5 to 7.1) | 2.9 (0.8 to 7.3) |
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Fever: >=38.0 degree C | 12.4 (6.8 to 20.2) | 0 (0.0 to 4.6) | 11.2 (5.7 to 19.2) |
| Fever: >=38.0 degree C to 38.4 degree C | 7.6 (3.3 to 14.5) | 0 (0.0 to 4.6) | 4.1 (1.1 to 10.1) |
| Fever: >38.4 degree C to 38.9 degree C | 1.9 (0.2 to 6.7) | 0 (0.0 to 4.6) | 4.1 (1.1 to 10.1) |
| Fever: >38.9 degree C to 40.0 degree C | 1.9 (0.2 to 6.7) | 0 (0.0 to 4.6) | 3.1 (0.6 to 8.7) |
| Fever: >40.0 degree C | 1.0 (0.0 to 5.2) | 0 (0.0 to 4.6) | 0 (0.0 to 3.7) |
| Decreased Appetite: Any | 20.0 (12.8 to 28.9) | 13.9 (7.2 to 23.5) | 23.5 (15.5 to 33.1) |
| Decreased Appetite: Mild | 14.3 (8.2 to 22.5) | 10.1 (4.5 to 19.0) | 13.3 (7.3 to 21.6) |
| Decreased Appetite: Moderate | 4.8 (1.6 to 10.8) | 3.8 (0.8 to 10.7) | 9.2 (4.3 to 16.7) |
| Decreased Appetite: Severe | 1.0 (0.0 to 5.2) | 0 (0.0 to 4.6) | 1.0 (0.0 to 5.6) |
| Drowsiness: Any | 33.3 (24.4 to 43.2) | 20.3 (12.0 to 30.8) | 29.6 (20.8 to 39.7) |
| Drowsiness: Mild | 25.7 (17.7 to 35.2) | 17.7 (10.0 to 27.9) | 20.4 (12.9 to 29.7) |
| Drowsiness: Moderate | 7.6 (3.3 to 14.5) | 2.5 (0.3 to 8.8) | 8.2 (3.6 to 15.5) |
| Drowsiness: Severe | 0 (0.0 to 3.5) | 0 (0.0 to 4.6) | 1.0 (0.0 to 5.6) |
| Irritability: Any | 60.0 (50.0 to 69.4) | 53.2 (41.6 to 64.5) | 46.9 (36.8 to 57.3) |
| Irritability: Mild | 24.8 (16.9 to 34.1) | 31.6 (21.6 to 43.1) | 21.4 (13.8 to 30.9) |
| Irritability: Moderate | 34.3 (25.3 to 44.2) | 20.3 (12.0 to 30.8) | 23.5 (15.5 to 33.1) |
| Irritability: Severe | 1.0 (0.0 to 5.2) | 1.3 (0.0 to 6.9) | 2.0 (0.2 to 7.2) |
Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of \>=38.0 degree Celsius and categorized as \>=38.0 to 38.4 degree Celsius,\>38.4 to 38.9 degree Celsius, \>38.9 to 40.0 degree Celsius and \>40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).
| Percentage of participants | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|
| Fever: >=38.0 degree C | 5.9 (1.9 to 13.2) |
| Fever: >=38.0 degree C to 38.4 degree C | 3.5 (0.7 to 10.0) |
| Fever: >38.4 degree C to 38.9 degree C | 1.2 (0.0 to 6.4) |
| Fever: >38.9 degree C to 40.0 degree C | 1.2 (0.0 to 6.4) |
| Fever: >40.0 degree C | 0 (0.0 to 4.2) |
| Decreased Appetite: Any | 11.8 (5.8 to 20.6) |
| Decreased Appetite: Mild | 8.2 (3.4 to 16.2) |
| Decreased Appetite: Moderate | 1.2 (0.0 to 6.4) |
| Decreased Appetite: Severe | 2.4 (0.3 to 8.2) |
| Drowsiness: Any | 21.2 (13.1 to 31.4) |
| Drowsiness: Mild | 17.6 (10.2 to 27.4) |
| Drowsiness: Moderate | 2.4 (0.3 to 8.2) |
| Drowsiness: Severe | 1.2 (0.0 to 6.4) |
| Irritability: Any | 30.6 (21.0 to 41.5) |
| Irritability: Mild | 15.3 (8.4 to 24.7) |
| Irritability: Moderate | 12.9 (6.6 to 22.0) |
| Irritability: Severe | 2.4 (0.3 to 8.2) |
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | 57.9 (50.1 to 65.4) | 65.3 (57.0 to 73.0) | 56.6 (48.7 to 64.3) |
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4 | 23.6 (16.1 to 32.7) | 15.3 (8.4 to 24.7) | 25.7 (17.6 to 35.4) |
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
| Percentage of participants | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|
| Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose | 18.2 (10.8 to 27.8) |
An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study | 4.1 (1.7 to 8.3) | 2.7 (0.7 to 6.8) | 5.4 (2.5 to 10.0) |
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study | 7.6 (4.1 to 12.6) | 3.4 (1.1 to 7.8) | 7.2 (3.8 to 12.3) |
IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.
| microgram per milliliter | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Serotype 8 | 2.90 (2.47 to 3.39) | 5.14 (4.41 to 5.99) | 0.03 (0.03 to 0.04) |
| Serotype 10A | 2.55 (1.95 to 3.34) | 4.52 (3.59 to 5.69) | 0.03 (0.03 to 0.04) |
| Serotype 11A | 4.37 (3.57 to 5.34) | 8.88 (7.25 to 10.87) | 0.01 (0.01 to 0.02) |
| Serotype 12F | 1.92 (1.58 to 2.34) | 3.35 (2.75 to 4.07) | 0.02 (0.02 to 0.02) |
| Serotype 15B | 9.12 (7.54 to 11.04) | 14.86 (12.65 to 17.44) | 0.05 (0.04 to 0.06) |
| Serotype 22F | 9.25 (7.50 to 11.41) | 23.94 (19.88 to 28.82) | 0.01 (0.01 to 0.01) |
| Serotype 33F | 3.40 (2.75 to 4.21) | 4.83 (3.99 to 5.84) | 0.06 (0.05 to 0.06) |
Percentage of participants with pre-specified IgG concentration (\>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.
| Percentage of participants | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Serotype 8 | 98.4 (94.5 to 99.8) | 100.0 (96.6 to 100.0) | 1.8 (0.2 to 6.5) |
| Serotype 10A | 89.8 (83.3 to 94.5) | 98.1 (93.4 to 99.8) | 2.8 (0.6 to 7.8) |
| Serotype 11A | 96.9 (92.2 to 99.1) | 99.1 (94.9 to 100.0) | 0.9 (0.0 to 5.0) |
| Serotype 12F | 95.3 (90.1 to 98.3) | 98.1 (93.4 to 99.8) | 0.0 (0.0 to 3.3) |
| Serotype 15B | 96.9 (92.2 to 99.1) | 100.0 (96.6 to 100.0) | 6.4 (2.6 to 12.8) |
| Serotype 22F | 96.9 (92.2 to 99.1) | 100.0 (96.6 to 100.0) | 0.0 (0.0 to 3.3) |
| Serotype 33F | 96.1 (91.1 to 98.7) | 99.1 (94.9 to 100.0) | 4.6 (1.5 to 10.4) |
IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.
| microgram per milliliter | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Serotype 8 | 3.79 (3.10 to 4.62) | 3.05 (2.46 to 3.78) | 0.08 (0.06 to 0.12) |
| Serotype 10A | 12.77 (10.16 to 16.06) | 7.15 (5.26 to 9.72) | 0.04 (0.03 to 0.04) |
| Serotype 11A | 8.25 (6.72 to 10.12) | 7.12 (5.53 to 9.15) | 0.02 (0.01 to 0.04) |
| Serotype 12F | 3.15 (2.64 to 3.74) | 2.57 (2.08 to 3.19) | 0.03 (0.02 to 0.03) |
| Serotype 15B | 24.56 (21.23 to 28.41) | 17.70 (14.31 to 21.89) | 0.06 (0.04 to 0.07) |
| Serotype 22F | 25.68 (21.33 to 30.91) | 29.92 (24.21 to 36.98) | 0.01 (0.01 to 0.02) |
| Serotype 33F | 5.38 (4.47 to 6.48) | 3.95 (3.16 to 4.93) | 0.06 (0.05 to 0.08) |
Collected over Local reactions, systemic events: within 7 days after Dose 1, 2, 3, 4, Supplemental Dose; Non-SAEs: from Dose 1 to 1 month after Dose 3, Dose 4 to 1 month after Dose 4, Supplemental Dose to 1 month after Supplemental Dose ; SAEs: Dose 1 to 6 months after last dose (Dose 4 or Supplemental Dose) (up to duration of 17 months). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: c7vPnC and Prevnar 13 Co-administration | 0/171 (0%) | 7/171 (4.1%) | 163/171 (95.3%) |
| Group 2: c7vPnC and Prevnar 13 Staggered Administration | 0/147 (0%) | 4/147 (2.7%) | 138/147 (93.9%) |
| Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | 0/166 (0%) | 9/166 (5.4%) | 163/166 (98.2%) |
| Event | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| BronchiolitisInfections and infestations | 2/171 | 1/147 | 3/166 |
| Pneumonia viralInfections and infestations | 0/171 | 0/147 | 2/166 |
| CellulitisInfections and infestations | 0/171 | 1/147 | 0/166 |
| Parotid abscessInfections and infestations | 0/171 | 1/147 | 0/166 |
| Subcutaneous abscessInfections and infestations | 0/171 | 1/147 | 0/166 |
| Urinary tract infectionInfections and infestations | 1/171 | 1/147 | 0/166 |
| Respiratory syncytial virus bronchiolitisInfections and infestations | 0/171 | 0/147 | 1/166 |
| Respiratory syncytial virus infectionInfections and infestations | 0/171 | 0/147 | 1/166 |
| Viral infectionInfections and infestations | 0/171 | 0/147 | 1/166 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/171 | 0/147 | 1/166 |
| Event | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose |
|---|---|---|---|
| Irritability (IRRITABILITY)Psychiatric disorders | 141/171 | 113/147 | 141/166 |
| Injection site pain (PAIN)General disorders | 131/171 | 82/147 | 112/166 |
| Somnolence (DROWSINESS)Nervous system disorders | 124/171 | 80/147 | 126/166 |
| Decreased appetite (DECREASED APPETITE)Metabolism and nutrition disorders | 82/171 | 51/147 | 84/166 |
| Injection site erythema (REDNESS)General disorders | 82/171 | 67/147 | 77/166 |
| Injection site swelling (SWELLING)General disorders | 74/171 | 49/147 | 68/166 |
| Pyrexia (FEVER)General disorders | 62/171 | 20/147 | 53/166 |
| Upper respiratory tract infectionInfections and infestations | 45/171 | 43/147 | 35/166 |
| Otitis mediaInfections and infestations | 11/171 | 17/147 | 13/166 |
| BronchiolitisInfections and infestations | 13/171 | 6/147 | 14/166 |
The overall safety population included all participants who received at least 1 dose of c7vPnC (in Groups 1 and 2) or Prevnar 13 (in Group 3) and had safety data reported in the study.
| Age, Continuous(Days) | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Total |
|---|---|---|---|---|
| Mean | 65.9 ± 9.53 | 95.1 ± 10.40 | 64.9 ± 8.22 | 74.4 ± 16.59 |
| Sex: Female, Male(Participants) | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Total |
|---|---|---|---|---|
| Female | 85 | 80 | 75 | 240 |
| Male | 86 | 67 | 91 | 244 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Total |
|---|---|---|---|---|
| Hispanic or Latino | 89 | 70 | 85 | 244 |
| Not Hispanic or Latino | 81 | 77 | 80 | 238 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Group 1: c7vPnC and Prevnar 13 Co-administration | Group 2: c7vPnC and Prevnar 13 Staggered Administration | Group 3: Prevnar 13 as Control With Supplemental c7vPnC Dose | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 8 | 3 | 15 |
| Asian | 7 | 5 | 3 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 35 | 26 | 31 | 92 |
| White | 102 | 90 | 105 | 297 |
| More than one race | 6 | 4 | 6 | 16 |
| Unknown or Not Reported | 17 | 14 | 17 | 48 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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