Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

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 vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.

Official Title
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A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.

Conditions
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Pneumococcal Infections

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 from 7 months to <72 months at time of enrollment. Available for entire study period and whose parent/legal guardian could be reached by telephone. Healthy as determined by medical history, physical examination, and judgment of the investigator. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal vaccine. A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with pneumococcal vaccine. 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 monoclonal antibodies) in the last 3 months. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable. Child 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: 7 Months
Maximum Age: 5 Years

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Biological: 13-valent Pneumococcal Conjugate Vaccine<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 After Vaccination | 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. | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). | 
| Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | 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. | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (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 | Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. | During the 4-day period after each dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal Vaccines