Wyeth 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 manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Official Title
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A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine

Conditions
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Pneumococcal Vaccines

Intervention / Treatment
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* Biological: 13-valent Pneumococcal Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged 2 months (42 to 98 days) at time of enrollment. Available for entire study period and whose parent/legal guardian can be reached by telephone. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. Parent/legal guardian must be able to complete all relevant study procedures during study participation. Exclusion criteria: Previous vaccination with licensed or investigational pneumococcal, 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, measles, mumps, rubella, 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 disorders. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®). Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.

Ages Eligible for Study
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Minimum Age: 41 Days
Maximum Age: 99 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* 1 dose at 2,3,4 and 12 months of age<br>|
| Active Comparator: 2<br> | Biological: 13-valent Pneumococcal Conjugate Vaccine<br>* 1 dose at 2,3,4 and 12 months of age<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 Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Percentages of participants achieving 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 (5 months of age) | 
| Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. | During the 4-day period after each dose | 
| Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category. | During the 4-day period after each dose | 
| Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category. | During the 4-day period after toddler dose | 
| Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Antibody concentration/geometric mean concentration (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 (5 months of age) |