Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Official Title
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A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

Conditions
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Vaccines, Pneumococcal

Intervention / Treatment
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* Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
* Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged 2 months (42 through 98 days) at the time of enrollment. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone. In good health as determined by medical history, physical examination, and judgment of the investigator. Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation. Exclusion criteria: Previous vaccination with licensed or investigational pneumococcal vaccine. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines. A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. Known or suspected immune deficiency or suppression. History of culture-proven invasive disease caused by S pneumoniae. Major known congenital malformation or serious chronic disorder. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 98 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80<br> <br> |
| Active Comparator: 2<br> | Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | One month after 3-dose infant series (at 5 months of age) | 
| Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series | GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | One month after 3-dose infant series (at 5 months of age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | one month after the toddler dose (at 13 months of age) | 
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. | one month after the toddler dose (at 13 months of age) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Infant