Study Evaluating Pneumococcal Vaccine in Healthy Infants

NCT00205803 | Completed Phase 1 Results

• 1 other identifier: 6096A1-003
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.

Conditions

Healthy Subjects; Pneumococcal Infections

Keywords

Infant Vaccine

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  Local reaction events were collected using a paper worksheet. 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 (Sev.)(\> 7.0 cm). Participants may be represented in more than 1 category.

  Within 15 days after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events

  Systemic events (fever \[Fv\] ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.

  Within 15 days after each dose

• Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

  Percentage 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. Exact 2-sided CI based on the observed proportion of participants.

  one month after 3-dose infant series (at 7 months of age)

Secondary Outcomes (12)

• Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

  One month after the toddler dose (at 13 to 16 months of age)

• Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

  One month after 3-dose infant series (at 7 months of age)

• Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose

  Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)

• Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series

  One month after the infant series (7 months of age)

• Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series

  one month after the infant series (7 months of age)

Study Arms (2)

13vPnC

EXPERIMENTAL

Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

7vPnC

ACTIVE COMPARATOR

Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

Interventions

13-Valent Pneumococcal Conjugate Vaccine (13vPnC) BIOLOGICAL

13vPnC

7-Valent Pneumococcal Conjugate Vaccine (7vPnC) BIOLOGICAL

7vPnC

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
• In good health as determined by medical history, physical examination and judgment of the investigator,
• Subject must have been born ≥36 weeks of gestational age,
• Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
• Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.

You may not qualify if:

• Previous vaccination with licensed or investigational pneumococcal vaccine,
• Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
• Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
• 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,
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
• History of culture-proven invasive disease caused by S. pneumoniae,
• Previous anaphylactic reaction to any vaccine or vaccine components,
• Major known congenital malformation or serious chronic disorders,
• Participation in another investigational study (however, observation-only trials are permitted),
• Known or suspected immune deficiency/suppression,
• Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

New York, New York, 10045, United States

Location

Related Publications (1)

• Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.

  PMID: 20435707 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2004
• Study Completion: May 1, 2007
• Last Updated: August 15, 2012
• Results First Posted: August 15, 2012

Record last verified: 2012-07

Locations

US (1)