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

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine

• Registration Number: NCT00452452
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-26
• Study First Posted: 2007-03-27
• Study Start: 2007-07
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Disposition First Submitted: 2009-01-21
• Disposition First Submitted QC: 2009-07-31
• Disposition First Posted: 2009-10-01
• Results First Submitted: 2010-03-26
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-06
• Last Update Submitted: 2012-07-06
• Results First Posted: 2012-08-15
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

1. Aged from 7 months to <72 months at time of enrollment.
2. Available for entire study period and whose parent/legal guardian could be reached by telephone.
3. Healthy as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Exclusion Criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. 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.
9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	13-valent Pneumococcal Conjugate Vaccine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination	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).	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.
Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups	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).	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Pre-Specified Local Reactions	During the 4-day period after each dose	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.
Percentage of Participants Reporting Pre-Specified Systemic Events	During the 4-day period after each dose	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.