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

• ClinicalTrials.gov Identifier: NCT00452452
• Recruitment Status: Completed
• First Posted: March 27, 2007
• Results First Posted: August 15, 2012
• Last Update Posted: August 15, 2012
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: March 23, 2007
• First Posted Date: March 27, 2007
• Results First Submitted Date: March 26, 2010
• Results First Posted Date: August 15, 2012
• Last Update Posted Date: August 15, 2012
• Study Start Date: July 2007
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 6, 2012)

• Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination [ Time Frame: 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 [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: March 26, 2007): To assess the pneumococcal immune responses induced by 13vPnC when measured 1 month after the last scheduled dose of 13vPnC in each of 3 age groups (Group A = 7-11 months; Group B = 12-23 months; Group C = 24 months-5 years).

Current Secondary Outcome Measures (submitted: July 6, 2012)

• Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures (submitted: March 26, 2007): To evaluate the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events (AEs).
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
• Official Title: 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Pneumococcal Infections
• Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine

Study Arms

Experimental: A

Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 6, 2012): 355
• Original Enrollment (submitted: March 26, 2007): 354
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Months to 5 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT00452452
• Other Study ID Numbers: 6096A1-3002
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• Original Responsible Party: Not Provided
• Current Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer
• Principal Investigator: Trial Manager; For Poland: WPWZMED@wyeth.com

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: July 2012