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

NCT00452452 | Completed Phase 3 Results

• 1 other identifier: 6096A1-3002
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 9

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.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  During the 4-day period after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events

  During the 4-day period after each dose

Study Arms (1)

A

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

Interventions

13-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

A

Eligibility Criteria

• Age: 7 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (9)

Unknown Facility

Bydgoszcz, 85-168, Poland

Location

Unknown Facility

Bydgoszcz, 85-316, Poland

Location

Unknown Facility

Dębica, 39-200, Poland

Location

Unknown Facility

Krakow, 31-503, Poland

Location

Unknown Facility

Lodz, 91-738, Poland

Location

Unknown Facility

Oborniki Salskie, 55-120, Poland

Location

Unknown Facility

Proznan, 61-709, Poland

Location

Unknown Facility

Trzebnica, 55-100, Poland

Location

Unknown Facility

Łęczna, 21-010, Poland

Location

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Poland: WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2007
• First Posted: March 27, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 15, 2012
• Results First Posted: August 15, 2012

Record last verified: 2012-07

Locations

PL (9)