CompletedNCT00680914Updated Jun 8, 2018Results posted

Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

A Phase 3 interventional study of Pneumococcal vaccine GSK1024850A (Synflorix) and Prevenar in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 14 sites in Korea, Republic of. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-08.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 503
Allocation: Randomized
Ages: 6 Weeks to 12 Weeks
Sex: All

Study summary

The purposes of this study are:

To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life.

To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.

Read the detailed description

Vaccination course at 2, 4, 6 months of age.

Conditions studied

Infections, Streptococcal

Browse trials for

Streptococcal Infections 155

Keywords

Streptococcus pneumoniae
pneumococcal conjugate vaccine

In context

Streptococcal Infections

155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.

This study's enrollment of 503 is above the median of 250 across 105 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Weeks to 12 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
Written and signed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
Free of any known or suspected health problems as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kilogram.

Exclusion criteria

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. Recommended live vaccines not included in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 503 participants (actual)

Study arms

Experimental
Synflorix Group
Subjects received 3 doses of Synflorix vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Biological: Pneumococcal vaccine GSK1024850A (Synflorix) · Biological: GSK Biologicals' Hiberix™
Active comparator
Prevenar Group
Subjects received 3 doses of Prevenar vaccine co-administered with Hiberix vaccine at Study Months 0, 2 and 4.
Biological: Prevenar · Biological: GSK Biologicals' Hiberix™

Interventions

BiologicalPneumococcal vaccine GSK1024850A (Synflorix)
3 doses administered intramuscularly.
BiologicalPrevenar
3 doses administered intramuscularly.
BiologicalGSK Biologicals' Hiberix™
3 doses administered intramuscularly.
Also known as: Hib

What researchers measure

Primary outcomes

Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after administration of 3rd dose of the pneumococcal conjugate vaccine

Secondary outcomes

Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes
Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations \>= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL. Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations \>= 0.05 ug/mL.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was \>= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). Pneumococcal cross-reactive serotypes were 6A and 19A.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine
Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Anti-PD Antibody Concentration
Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.
Time frame: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes
The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as \>= 8.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
Concentration of anti-PRP antibody given as GMC in ug/mL.
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Number of Subjects With Seroprotection Status Against PRP
Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL
Time frame: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: Within 4 days after each vaccination
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature \>= 37.5 degrees Celsius.
Time frame: Within 4 days after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: Within 31 days after each vaccination
Number of Subjects With Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5

Results

Posted Jun 14, 2010

Participant flow

Participant flow — Overall Study
Milestone	Synflorix Group	Prevenar Group
Started	374	129
Completed	364	125
Not completed	10	4
Withdrew: Consent withdrawal	6	3
Withdrew: Lost to follow-up	4	0
Withdrew: Serious adverse event (sae)	0	1

Outcome measures

PrimaryNumber of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Time frame:: One month after administration of 3rd dose of the pneumococcal conjugate vaccine
Reported as:: Number · subjects

Number of Subjects With Vaccine Pneumococcal Serotypes Antibody Concentrations Above the Cut-Off Value
subjects	Synflorix Group	Prevenar Group
Anti-1	344	7
Anti-4	343	123
Anti-5	344	18
Anti-6B	318	121
Anti-7F	344	4
Anti-9V	343	122
Anti-14	342	123
Anti-18C	343	123
Anti-19F	340	123
Anti-23F	331	121

SecondaryNumber of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes

Seropositivity status for protein D is defined as anti protein D (anti-PD) antibody concentrations \>= 100 Enzyme-Linked Immuno Sorbent Assay (EL) units EL.U/mL. Seropositivity status for pneumococcal serotypes is defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations \>= 0.05 ug/mL.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Number · subjects

Number of Subjects With a Seropositivity Status Against Protein D and Defined Pneumococcal Serotypes
subjects	Synflorix Group	Prevenar Group
Anti-PD	343	123
Anti-1	344	44
Anti-4	344	123
Anti-5	344	85
Anti-6B	337	122
Anti-7F	344	22
Anti-9V	343	123
Anti-14	344	123
Anti-18C	344	123
Anti-19F	344	123
Anti-23F	340	122

SecondaryNumber of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value

The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was \>= 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Number · subjects

Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Contained in the Vaccine Above the Cut-off Value
subjects	Synflorix Group	Prevenar Group
Opsono-1 (N=162; 62)	150	8
Opsono-4 (N=161; 63)	158	63
Opsono-5 (N=165; 62)	161	6
Opsono-6B (N=162; 63)	152	63
Opsono-7F (N=164; 59)	164	40
Opsono-9V (N= 165; 63)	164	62
Opsono-14 (N= 165; 63)	163	62
Opsono-18C (N= 159; 63)	142	61
Opsono-19F (N=164; 61)	159	55
Opsono-23F (N= 164; 63)	160	62

SecondaryNumber of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (ug/mL). Pneumococcal cross-reactive serotypes were 6A and 19A.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Number · subjects

Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
subjects	Synflorix Group	Prevenar Group
Anti-6A	232	85
Anti-19A	203	33

SecondaryAntibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine

Concentrations are reported as Geometric Mean Concentrations in ug/mL. Pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Geometric mean · ug/mL

Antibody Concentrations Against Pneumococal Serotypes Contained in the Vaccine
ug/mL	Synflorix Group	Prevenar Group
Anti-1	3.41 (3.14 to 3.71)	0.04 (0.04 to 0.05)
Anti-4	4.00 (3.67 to 4.35)	5.35 (4.66 to 6.15)
Anti-5	4.52 (4.24 to 4.83)	0.07 (0.06 to 0.08)
Anti-6B	1.40 (1.24 to 1.58)	2.07 (1.75 to 2.44)
Anti-7F	4.08 (3.77 to 4.41)	0.03 (0.03 to 0.04)
Anti-9V	3.39 (3.09 to 3.71)	5.09 (4.34 to 5.96)
Anti-14	5.54 (5.02 to 6.12)	8.51 (7.27 to 9.95)
Anti-18C	5.80 (5.17 to 6.52)	5.13 (4.31 to 6.11)
Anti-19F	7.41 (6.67 to 8.23)	2.77 (2.45 to 3.13)
Anti-23F	1.96 (1.75 to 2.19)	3.94 (3.26 to 4.77)

SecondaryAnti-PD Antibody Concentration

Concentration of anti-PD antibody given as GMC expressed in EL.U/mL.

Time frame:: One month after administration of 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Geometric mean · EL.U/mL

Anti-PD Antibody Concentration
EL.U/mL	Synflorix Group	Prevenar Group
Anti-PD Antibody Concentration	1622.4 (1500.8 to 1754.0)	88.2 (74.7 to 104.0)

SecondaryAntibody Concentrations Against Pneumococcal Cross-reactive Serotypes

Concentration of cross-reactive pneumococcal serotypes 6A and 19A in ug/mL.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Geometric mean · ug/mL

Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes
ug/mL	Synflorix Group	Prevenar Group
Anti-6A	0.38 (0.33 to 0.44)	0.48 (0.36 to 0.63)
Anti-19A	0.29 (0.25 to 0.33)	0.12 (0.10 to 0.14)

SecondaryNumber of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes

The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. In this assay the cut-off value for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A was defined as \>= 8.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Number · subjects

Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes
subjects	Synflorix Group	Prevenar Group
Opsono-6A (N=158; 60)	134	54
Opsono-19A (N= 162; 60)	53	7

SecondaryAnti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

Concentration of anti-PRP antibody given as GMC in ug/mL.

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Geometric mean · ug/mL

Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
ug/mL	Synflorix Group	Prevenar Group
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations	20.131 (16.775 to 24.158)	11.844 (8.542 to 16.424)

SecondaryNumber of Subjects With Seroprotection Status Against PRP

Seroprotection status is defined as anti-PRP antibody concentrations above 0.15 ug/mL and above 1.0 ug/mL

Time frame:: One month after the administration of the 3rd vaccine dose of the pneumococcal conjugate vaccine
Reported as:: Number · subjects

Number of Subjects With Seroprotection Status Against PRP
subjects	Synflorix Group	Prevenar Group
Above 0.15	175	60
Above 1.0	173	58

SecondaryNumber of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Time frame:: Within 4 days after each vaccination
Reported as:: Number · subjects

Number of Subjects Reporting Solicited Local Symptoms
subjects	Synflorix Group	Prevenar Group
Pain	210	72
Redness	252	84
Swelling	182	69

SecondaryNumber of Subjects With Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature \>= 37.5 degrees Celsius.

Time frame:: Within 4 days after each vaccination
Reported as:: Number · subjects

Number of Subjects With Solicited General Symptoms
subjects	Synflorix Group	Prevenar Group
Drowsiness	212	65
Fever	113	33
Irritability	293	99
Loss of Appetite	177	66

SecondaryNumber of Subjects Reporting Unsolicited Adverse Events

Time frame:: Within 31 days after each vaccination
Reported as:: Number · subjects

Number of Subjects Reporting Unsolicited Adverse Events
subjects	Synflorix Group	Prevenar Group
Number of Subjects Reporting Unsolicited Adverse Events	213	62

SecondaryNumber of Subjects With Serious Adverse Events (SAE)

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time frame:: Following the administration of the first dose of the study vaccines throughout the entire study period up to study month 5
Reported as:: Number · subjects

Number of Subjects With Serious Adverse Events (SAE)
subjects	Synflorix Group	Prevenar Group
Number of Subjects With Serious Adverse Events (SAE)	56	9

Adverse events

Collected over Up to study Month 5. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Synflorix Group	—	56/374 (15%)	357/374 (95.5%)
Prevenar Group	—	9/129 (7%)	124/129 (96.1%)

Most frequent serious events

Showing 10 of 30

Most frequent serious events
Event	Synflorix Group	Prevenar Group
BronchiolitisInfections and infestations	22/374	1/129
Urinary tract infectionInfections and infestations	9/374	1/129
GastroenteritisInfections and infestations	8/374	3/129
PneumoniaInfections and infestations	4/374	1/129
PharyngitisInfections and infestations	3/374	0/129
Croup infectionsInfections and infestations	2/374	1/129
IntussusceptionGastrointestinal disorders	2/374	1/129
Meningitis asepticInfections and infestations	2/374	1/129
enteritisGastrointestinal disorders	1/374	1/129
AnorexiaMetabolism and nutrition disorders	0/374	1/129

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Synflorix Group	Prevenar Group
IrritabilityGeneral disorders	293/374	99/129
RednessGeneral disorders	252/374	84/129
DrowsinessGeneral disorders	212/374	65/129
PainGeneral disorders	210/374	72/129
SwellingGeneral disorders	182/374	69/129
Loss of appetiteGeneral disorders	177/374	66/129
FeverGeneral disorders	113/374	33/129
Upper respiratory tract infectionInfections and infestations	44/374	16/129
NasopharyngitisInfections and infestations	42/374	16/129
PharyngitisInfections and infestations	23/374	6/129

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Synflorix Group	Prevenar Group	Total
Mean	9.5 ± 1.49	9.5 ± 1.43	9.5 ± 1.47

Sex: Female, Male
Sex: Female, Male(Participants)	Synflorix Group	Prevenar Group	Total
Female	189	71	260
Male	185	58	243

Region of Enrollment
Region of Enrollment(participants)	Synflorix Group	Prevenar Group	Total
East Asia	373	129	502 ± 0
Southeast Asia	1	0	1 ± 0

Study locations

14 sites

GSK Investigational Site
Ansan, 425-707, Korea, Republic of
GSK Investigational Site
Bucheon-si,, 420-767, Korea, Republic of
GSK Investigational Site
Daejeon, 301-723, Korea, Republic of
GSK Investigational Site
Gyeongnam, 641-560, Korea, Republic of
GSK Investigational Site
Iksan, 570-711, Korea, Republic of
GSK Investigational Site
Jeju, 690-716, Korea, Republic of
GSK Investigational Site
Jeonju Jeonbuk, 561-712, Korea, Republic of
GSK Investigational Site
Pusan, 602-739, Korea, Republic of
GSK Investigational Site
Seoul, 130-702, Korea, Republic of
GSK Investigational Site
Seoul, 150-719, Korea, Republic of
GSK Investigational Site
Seoul, 158-710, Korea, Republic of
GSK Investigational Site
Seoul, 411-706, Korea, Republic of
GSK Investigational Site
Suwon City, 442-723, Korea, Republic of
GSK Investigational Site
Wonju-si Kangwon-do, 220-701, Korea, Republic of

References and documents

Publications

Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541. PubMed 21817957 ↗
Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
Kim CH et al. Immunogenicity of a 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) and co-administered vaccines following primary vaccination in Asian infants. Abstract presented at the 5th Asian Congress of Pediatric Infectious Diseases (ACPID). Taipei, Taiwan, 23-26 September 2010.
Kim JS et al. Safety and reactogenicity of primary vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Kim KH et al. Immunogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean infants. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12. PubMed 21994351 ↗
Schuerman L et al. Immune responses against cross-reactive pneumococcal serotypes 6A and 19A with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. OPA assay is more reliable predictor of vaccine effectiveness against invasive pneumococcal disease (IPD) than ELISA antibody measurements. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00680914
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: May 20, 2008
Start date: Jun 10, 2008
Primary completion: May 8, 2009
Completion: May 8, 2009
Results posted: Jun 14, 2010
Last update: Jun 8, 2018

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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