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CompletedNCT04508309Updated Jan 30, 2025Results posted

Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls

A Phase 3 interventional study of Cecolin® and Gardasil® in Cervical Cancer, sponsored by PATH. Completed at 2 sites in 2 countries. Open to female participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by PATH · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,025
Allocation
Randomized
Ages
9 Years to 14 Years
Sex
Female
01

Study summary

This randomized controlled trial will evaluate a bivalent HPV vaccine, Cecolin®, in alternate 2-dose regimens, compared to an established HPV vaccine. Gardasil® will be used as the comparator vaccine, as this vaccine is most widely used in low- and low-middle income countries.

Read the detailed description

This randomized, active-comparator controlled, open-label study will enroll total of approximately 1025 girls aged 9 to 14 years, in one country in Africa (Ghana) and one country in South/Southeast Asia (Bangladesh). Participants will be randomized 1:1:1:1:1 to receive Cecolin® at 0 and 6 months, 0 and 12 months, or 0 and 24 months, Gardasil® at 0 and 6 months, or Gardasil® at 0 months and Cecolin® at 24 months. For each arm, blood will be collected for immunologic testing at baseline and one month following second dose. Additional blood collections will occur immediately prior to the administration of the second dose, as well as at additional later time points, for immunobridging to other published and ongoing trials. The study also aims to evaluate the performance of a mixed arm (group 5) of Gardasil® followed by Cecolin® and collect data on effects of interchangeability.

Girls of target age will be identified, and their parents contacted to attend an informational session for individual discussion, informed consent, assent and randomization.

The study will be conducted by the research groups in International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in Bangladesh and the Malaria Research Center (MRC) in Ghana.

02

Conditions studied

  • Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.

This study's enrollment of 1,025 is above the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

PATH is the lead sponsor of 111 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

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

04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy (determined by investigator's assessment following medical history and physical examination, laboratory evaluation could be performed at the investigator's discretion) female between the ages of 9 - 14 years (all inclusive) at time of enrollment
  2. Ability and willingness to provide parental consent and, if applicable based on local in-country regulations, participant assent
  3. Parent/Legally Acceptable Representative provides informed consent
  4. Anticipated ability and willingness to complete all study visits and evaluations
  5. Living within the catchment area of the study without plans to move during the conduct of the study

Exclusion criteria

Exclusion Criteria:

  1. Presence of fever or acute disease on the day of vaccination (oral or axillary temperature ≥ 38˚ C)
  2. If participants have childbearing potential, must not be breastfeeding or confirmed pregnant
  3. Receipt of an investigational product within 30 days prior to randomization
  4. Receipt of blood and/or blood products (including immunoglobulin) 3 months prior to any dose of vaccination or blood sampling
  5. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as Measles, Mumps, and Rubella (MMR), or yellow fever vaccine but not including live attenuated influenza virus vaccine) 4 weeks prior and after each dose of HPV vaccine
  6. History of any physical, mental, or developmental disorder that may hinder a participant's ability to comply with the study requirements
  7. Any malignancy or confirmed or suspected immunodeficient condition such as HIV infection, based on medical history and physical examination
  8. Receipt of or history of receipt of any medications or treatments that affect the immune system
  9. Allergies to any components of the vaccine
  10. Current or former participation in HPV vaccine related research.
  11. Prior receipt of an investigational or licensed HPV vaccine
  12. Any other condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,025 participants (actual)

Study arms

  • Experimental
    Cecolin® at 0 and 6 months

    Two doses of Cecolin® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose

    Biological: Cecolin®

  • Experimental
    Cecolin® at 0 and 12 months

    Two doses of Cecolin® given at 0 and 12 months with blood draw at baseline, prior to second dose and one-month post second dose

    Biological: Cecolin®

  • Experimental
    Cecolin® at 0 and 24 months

    Two doses of Cecolin® given at 0 and 24 months with blood draw at baseline, prior to second dose and one-month post second dose

    Biological: Cecolin®

  • Active comparator
    Gardasil® at 0 and 6 months

    Two doses of Gardasil® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose

    Biological: Gardasil®

  • Other
    Gardasil® at 0 and Cecolin® at 24 months

    One dose of Gardasil® at 0 months and one dose of Cecolin® at 24 months with blood draw at baseline, prior to second dose and one-month post second dose.

    Biological: Cecolin® · Biological: Gardasil®

Interventions

  • BiologicalCecolin®

    Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine

  • BiologicalGardasil®

    Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine

06

What researchers measure

Primary outcomes

  1. Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose

    Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.

    Time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).

  2. Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose

    Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.05 IU/mL.

    Time frame: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).

Secondary outcomes

  1. Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies

    Anti-HPV 16 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 PBNA was a titer of \< 21. Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.

    Time frame: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only

  2. Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies

    Anti-HPV 18 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 PBNA was a titer of \< 16. Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.

    Time frame: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only

  3. Seroconversion Rate For HPV-16 One Month After the Second Dose

    Seroconversion rate is defined as the percentage of participants with a 4-fold rise in anti-HPV 16 IgG antibodies as measured by ELISA from baseline one month following the second dose.

    Time frame: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).

  4. Seroconversion Rate For HPV-18 One Month After the Second Dose

    Seroconversion rate is defined as the percentage of participants with a 4-fold rise from baseline in anti HPV-18 IgG antibodies as measured by ELISA one month following the second dose.

    Time frame: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).

  5. GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen

    Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 IU/mL. Anti-HPV-16 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).

    Time frame: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).

  6. GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen

    Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.405 IU/mL. Anti-HPV-18 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 Months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).

    Time frame: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).

  7. GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose

    Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.

    Time frame: 18 months after the second dose (Month 24)

  8. GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose

    Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.

    Time frame: 18 months after the second dose (Month 24)

  9. Number of Participants With Solicited Adverse Events

    Solicited adverse events (AEs) were assessed by study staff 30 minutes after each vaccination and then daily for seven days after each vaccination by the participants using a memory aid. The following specific solicited AEs were monitored for this trial: * Local Reactions: * Pain, erythema/redness, swelling, induration, pruritus, abscess. * General/Systemic Reactions: * Fever (oral or axillary temperature ≥ 38.0°C), headache, vomiting, nausea, fatigue, chills, muscle pain, cough, diarrhea, dizziness, allergic dermatitis, rash, syncope, and anorexia.

    Time frame: For 30 minutes after each vaccination and for up to 7 days after each vaccination

  10. Number of Participants With Unsolicited Adverse Events

    Unsolicited AEs were any AEs reported spontaneously by the participant, identified during interview at study visits, observed by the study personnel during study visits or those identified during review of medical records or source documents. Unsolicited AEs were events occurring from the time of each study injection through approximately 30 days after each vaccination. Solicited AEs with onset after the solicitation period and through Day 30 post-vaccination were captured as unsolicited AEs.

    Time frame: For 30 days after each dose (Month 0 (all groups), Month 6 (Groups 1 and 4), Month 12 (Group 2), and Month 24 (Groups 3 and 5)

  11. Number of Participants With Serious Adverse Events (SAEs)

    An SAE was any AE that resulted in any of the following outcomes: 1. Death 2. Was life-threatening 3. Required inpatient hospitalization or prolongation of existing hospitalization. 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital abnormality or birth defect. 6. Important medical event that may not have resulted in one of the above outcomes but may have jeopardized the health of the study participant or (and) required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAEs. SAEs were collected from the time of first vaccination through the end of the study for each participant.

    Time frame: From first dose through the end of study (up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5)

Other outcomes

  1. GMC of Anti-HPV-16 IgG Antibodies Prior to the Second Dose

    To evaluate the persistence of antibody responses to HPV after a single dose of vaccine, anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA immediately prior to the second dose.

    Time frame: Prior to the second dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5).

  2. GMC of Anti-HPV-18 IgG Antibodies Prior to the Second Dose

    To evaluate the persistence of antibody responses to HPV after a single dose of vaccine, anti-HPV-18 IgG antibodies were measured using HPV-16 VLP ELISA immediately prior to the second dose.

    Time frame: Prior to the second dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5).

07

Results

Posted Jan 30, 2025

Participant flow

The study was conducted in one clinical site in Bangladesh and one clinical site in Ghana.

Participant flow — Overall Study
Milestone1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Started205206204205205
Received first vaccination205206204205205
Received second vaccination205204199205201
Completed205206203204203
Not completed00112
Withdrew: Death00001
Withdrew: Lost to follow-up00110
Withdrew: Withdrawal by subject00001

Outcome measures

PrimaryGeometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose

Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.

Time frame:
One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Reported as:
Geometric mean · IU/mL
Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose
IU/mL1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose1507.4 (1329.0 to 1709.7)2408.7 (2116.0 to 2741.8)3326.1 (2960.6 to 3736.7)1352.4 (1199.1 to 1525.3)2387.3 (2091.4 to 2725.1)
Statistical analysis
  • 1. Cecolin at Month 0 and 6 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.09 · 98.3% CI 0.891 to 1.327GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
  • 2. Cecolin at Month 0 and 12 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.78 · 98.3% CI 1.455 to 2.176GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
  • 3. Cecolin at Month 0 and 24 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 2.37 · 98.3% CI 1.942 to 2.903GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
PrimaryGeometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose

Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.05 IU/mL.

Time frame:
One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Reported as:
Geometric mean · IU/mL
Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose
IU/mL1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose382.7 (337.8 to 433.6)534.7 (469.4 to 609.1)535.2 (474.9 to 603.3)306.1 (269.3 to 347.9)379.0 (327.7 to 438.3)
Statistical analysis
  • 1. Cecolin at Month 0 and 6 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.25 · 98.3% CI 1.022 to 1.539GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
  • 2. Cecolin at Month 0 and 12 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.68 · 98.3% CI 1.372 to 2.069GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
  • 3. Cecolin at Month 0 and 24 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.71 · 98.3% CI 1.389 to 2.102GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
SecondaryGeometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies

Anti-HPV 16 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 PBNA was a titer of \< 21. Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.

Time frame:
Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies
titer1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Prior to Second Dose104.0 (78.6 to 137.7)95.1 (73.3 to 123.4)125.7 (95.3 to 165.6)71.6 (53.5 to 95.9)125.4 (85.2 to 184.5)
One Month after Second Dose16790.9 (11641.2 to 24218.6)32019.5 (25010.5 to 40992.7)48615.4 (36061.1 to 65540.5)14281.3 (10531.8 to 19365.7)31459.0 (24294.7 to 40736.0)
18-Months after Second Dose1541.9 (1076.9 to 2207.5)——1368.1 (998.8 to 1874.0)—
SecondaryGeometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies

Anti-HPV 18 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 PBNA was a titer of \< 16. Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.

Time frame:
Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies
titer1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Prior to Second Dose65.9 (42.1 to 103.2)51.1 (40.7 to 64.2)77.9 (58.1 to 104.5)47.6 (38.9 to 58.2)55.8 (36.3 to 85.6)
One Month after Second Dose6081.5 (3547.7 to 10425.1)9303.8 (7111.0 to 12172.7)11205.3 (8351.2 to 15034.8)6774.4 (5044.5 to 9097.6)7548.9 (5473.5 to 10411.2)
18-Months after Second Dose441.7 (301.8 to 646.5)——423.4 (289.8 to 618.5)—
SecondarySeroconversion Rate For HPV-16 One Month After the Second Dose

Seroconversion rate is defined as the percentage of participants with a 4-fold rise in anti-HPV 16 IgG antibodies as measured by ELISA from baseline one month following the second dose.

Time frame:
Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Reported as:
Number · percentage of participants
Seroconversion Rate For HPV-16 One Month After the Second Dose
percentage of participants1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Seroconversion Rate For HPV-16 One Month After the Second Dose100100100100100
SecondarySeroconversion Rate For HPV-18 One Month After the Second Dose

Seroconversion rate is defined as the percentage of participants with a 4-fold rise from baseline in anti HPV-18 IgG antibodies as measured by ELISA one month following the second dose.

Time frame:
Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Reported as:
Number · percentage of participants
Seroconversion Rate For HPV-18 One Month After the Second Dose
percentage of participants1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Seroconversion Rate For HPV-18 One Month After the Second Dose100100100100100
SecondaryGMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen

Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 IU/mL. Anti-HPV-16 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).

Time frame:
One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).
Reported as:
Geometric mean · IU/mL
GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
IU/mL4. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen1352.4 (1199.1 to 1525.3)2387.3 (2091.4 to 2725.1)
Statistical analysis
  • 4. Gardasil at Month 0 and 6 vs 5. Gardasil at Month 0 and Cecolin at Month 24 · Gmc ratio: 1.75 · 95% CI 1.476 to 2.071GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
SecondaryGMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen

Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.405 IU/mL. Anti-HPV-18 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 Months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).

Time frame:
One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).
Reported as:
Geometric mean · IU/mL
GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
IU/mL4. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen306.1 (269.3 to 347.9)379.0 (327.7 to 438.3)
Statistical analysis
  • 4. Gardasil at Month 0 and 6 vs 5. Gardasil at Month 0 and Cecolin at Month 24 · Gmc ratio: 1.21 · 95% CI 1.004 to 1.451GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
SecondaryGMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose

Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.

Time frame:
18 months after the second dose (Month 24)
Reported as:
Geometric mean · IU/mL
GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose
IU/mL1. Cecolin at Month 0 and 64. Gardasil at Month 0 and 6
GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose138.5 (120.8 to 158.7)119.1 (104.1 to 136.2)
Statistical analysis
  • 1. Cecolin at Month 0 and 6 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.12 · 95% CI 0.933 to 1.344GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
SecondaryGMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose

Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.

Time frame:
18 months after the second dose (Month 24)
Reported as:
Geometric mean · IU/mL
GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose
IU/mL1. Cecolin at Month 0 and 64. Gardasil at Month 0 and 6
GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose30.2 (25.9 to 35.2)23.2 (19.8 to 27.3)
Statistical analysis
  • 1. Cecolin at Month 0 and 6 vs 4. Gardasil at Month 0 and 6 · Gmc ratio: 1.32 · 95% CI 1.070 to 1.635GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.
SecondaryNumber of Participants With Solicited Adverse Events

Solicited adverse events (AEs) were assessed by study staff 30 minutes after each vaccination and then daily for seven days after each vaccination by the participants using a memory aid. The following specific solicited AEs were monitored for this trial: * Local Reactions: * Pain, erythema/redness, swelling, induration, pruritus, abscess. * General/Systemic Reactions: * Fever (oral or axillary temperature ≥ 38.0°C), headache, vomiting, nausea, fatigue, chills, muscle pain, cough, diarrhea, dizziness, allergic dermatitis, rash, syncope, and anorexia.

Time frame:
For 30 minutes after each vaccination and for up to 7 days after each vaccination
Reported as:
Count of participants · Participants
Number of Participants With Solicited Adverse Events
Participants1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Within 30 Minutes of Vaccination: Any Local Reactions4152125
Within 30 Minutes of Vaccination: Any Systemic Reactions1237107
Within 7 Days of Vaccination: Any Local Reactions131113106138120
Within 7 Days of Vaccination: Any Systemic Reactions7259487650
SecondaryNumber of Participants With Unsolicited Adverse Events

Unsolicited AEs were any AEs reported spontaneously by the participant, identified during interview at study visits, observed by the study personnel during study visits or those identified during review of medical records or source documents. Unsolicited AEs were events occurring from the time of each study injection through approximately 30 days after each vaccination. Solicited AEs with onset after the solicitation period and through Day 30 post-vaccination were captured as unsolicited AEs.

Time frame:
For 30 days after each dose (Month 0 (all groups), Month 6 (Groups 1 and 4), Month 12 (Group 2), and Month 24 (Groups 3 and 5)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events
Participants1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Number of Participants With Unsolicited Adverse Events4341465234
SecondaryNumber of Participants With Serious Adverse Events (SAEs)

An SAE was any AE that resulted in any of the following outcomes: 1. Death 2. Was life-threatening 3. Required inpatient hospitalization or prolongation of existing hospitalization. 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital abnormality or birth defect. 6. Important medical event that may not have resulted in one of the above outcomes but may have jeopardized the health of the study participant or (and) required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAEs. SAEs were collected from the time of first vaccination through the end of the study for each participant.

Time frame:
From first dose through the end of study (up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5)
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs)
Participants1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Number of Participants With Serious Adverse Events (SAEs)40543
Other pre-specifiedGMC of Anti-HPV-16 IgG Antibodies Prior to the Second Dose

To evaluate the persistence of antibody responses to HPV after a single dose of vaccine, anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA immediately prior to the second dose.

Time frame:
Prior to the second dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5).
Reported as:
Geometric mean · IU/mL
GMC of Anti-HPV-16 IgG Antibodies Prior to the Second Dose
IU/mL1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
GMC of Anti-HPV-16 IgG Antibodies Prior to the Second Dose17.5 (15.6 to 19.7)12.6 (11.0 to 14.6)12.0 (10.3 to 13.9)11.1 (9.9 to 12.3)10.5 (9.0 to 12.3)
Other pre-specifiedGMC of Anti-HPV-18 IgG Antibodies Prior to the Second Dose

To evaluate the persistence of antibody responses to HPV after a single dose of vaccine, anti-HPV-18 IgG antibodies were measured using HPV-16 VLP ELISA immediately prior to the second dose.

Time frame:
Prior to the second dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5).
Reported as:
Geometric mean · IU/mL
GMC of Anti-HPV-18 IgG Antibodies Prior to the Second Dose
IU/mL1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
GMC of Anti-HPV-18 IgG Antibodies Prior to the Second Dose6.5 (5.9 to 7.3)4.3 (3.8 to 4.9)4.4 (3.8 to 5.1)4.1 (3.6 to 4.6)3.2 (2.7 to 3.8)

Adverse events

Collected over Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1. Cecolin at Month 0 and 60/205 (0%)4/205 (2%)155/205 (75.6%)
2. Cecolin at Month 0 and 120/206 (0%)0/206 (0%)145/206 (70.4%)
3. Cecolin at Month 0 and 240/204 (0%)5/204 (2.5%)130/204 (63.7%)
4. Gardasil at Month 0 and 60/205 (0%)4/205 (2%)165/205 (80.5%)
5. Gardasil at Month 0 and Cecolin at Month 241/205 (0.5%)3/205 (1.5%)145/205 (70.7%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
Event1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
AbscessInfections and infestations0/2050/2061/2040/2050/205
AppendicitisInfections and infestations0/2050/2061/2040/2050/205
GastroenteritisInfections and infestations0/2050/2061/2040/2050/205
Animal biteInjury, poisoning and procedural complications0/2050/2061/2040/2050/205
Skin lacerationInjury, poisoning and procedural complications0/2050/2061/2040/2050/205
Inguinal herniaGastrointestinal disorders1/2050/2060/2040/2050/205
Umbilical herniaGastrointestinal disorders0/2050/2060/2041/2050/205
PyrexiaGeneral disorders1/2050/2060/2040/2050/205
Bacterial sepsisInfections and infestations0/2050/2060/2040/2051/205
CellulitisInfections and infestations0/2050/2060/2040/2051/205
Most frequent other events
Showing 10 of 18
Most frequent other events
Event1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24
Vaccination site painGeneral disorders133/205119/206106/204141/205121/205
HeadacheNervous system disorders40/20536/20633/20450/20531/205
MyalgiaMusculoskeletal and connective tissue disorders11/2056/2067/20422/20510/205
CoughRespiratory, thoracic and mediastinal disorders17/20514/2065/20414/2057/205
MalariaInfections and infestations9/2057/20611/2049/2056/205
Upper respiratory tract infectionInfections and infestations10/20510/20610/20410/20511/205
DizzinessNervous system disorders11/2058/2068/2048/2056/205
FatigueGeneral disorders5/2052/20610/2045/2056/205
VomitingGastrointestinal disorders6/2052/2065/20410/2052/205
PyrexiaGeneral disorders5/2053/2064/2049/2054/205

Baseline characteristics

Age, Continuous
Age, Continuous(years)1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24Total
Mean11.4 ± 1.4611.4 ± 1.3711.4 ± 1.4711.3 ± 1.3911.3 ± 1.4911.3 ± 1.44
Sex: Female, Male
Sex: Female, Male(Participants)1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24Total
Female2052062042052051025
Male000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24Total
Asian135136134135135675
Black7070707070350
Region of Enrollment
Region of Enrollment(participants)1. Cecolin at Month 0 and 62. Cecolin at Month 0 and 123. Cecolin at Month 0 and 244. Gardasil at Month 0 and 65. Gardasil at Month 0 and Cecolin at Month 24Total
Ghana7070707070350
Bangladesh135136134135135675
08

Study locations

2 sites
  • International Centre for Diarrhoeal Disease Research
    Dhaka, Bangladesh
  • Malaria Research Centre, Agogo Presbyterian Hospital
    Agogo, Ghana
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References and documents

Publications

  • Zaman K, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PB, Qadri F, Kemp TJ, Hossain L, Pinto LA, Sukraw K, Bhat N, Agbenyega T. Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9-14 years of age: Interim analysis from a phase 3 clinical trial. Vaccine. 2024 Apr 2;42(9):2290-2298. doi: 10.1016/j.vaccine.2024.02.077. Epub 2024 Mar 1. PubMed 38431444 ↗

Study documents

  • Study protocol · Feb 3, 2023
  • Statistical analysis plan · Nov 3, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04508309
Lead sponsor
PATH
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh, Malaria Research Centre, Agogo Presbyterian Hospital, Ghana, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA, The Emmes Company, LLC, Xiamen Innovax Biotech Co., Ltd
Responsible party
Sponsor
First posted
Aug 11, 2020
Start date
Mar 15, 2021
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Results posted
Jan 30, 2025
Last update
Jan 30, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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