Study Evaluating Pneumococcal Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00205803
First received: September 19, 2005
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Pneumococcal Infections
Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: Within 15 days after each dose ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: Within 15 days after each dose ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after 3-dose infant series (at 7 months of age) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (at 13 to 16 months of age) ] [ Designated as safety issue: No ]
    Percentages of participants achieving 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.

  • Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: One month after 3-dose infant series (at 7 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean concentration (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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.

  • Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [ Time Frame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) ] [ Designated as safety issue: No ]
    Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.

  • 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 [ Time Frame: One month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.

  • Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
    GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.

  • Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series [ Time Frame: one month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after the infant series (7 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.

  • Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the toddler dose (13 to 16 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer.

  • Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: One month after the Toddler Dose (13 to 16 months of age) ] [ Designated as safety issue: No ]
    Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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) were assessed. Results are reported for the serotypes with a determinate antibody titer.


Enrollment: 249
Study Start Date: September 2004
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: 13vPnC Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Active Comparator: 7vPnC Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
  2. In good health as determined by medical history, physical examination and judgment of the investigator,
  3. Subject must have been born ≥36 weeks of gestational age,
  4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
  5. 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.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine,
  2. Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
  3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
  4. 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,
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
  6. History of culture-proven invasive disease caused by S. pneumoniae,
  7. Previous anaphylactic reaction to any vaccine or vaccine components,
  8. Major known congenital malformation or serious chronic disorders,
  9. Participation in another investigational study (however, observation-only trials are permitted),
  10. Known or suspected immune deficiency/suppression,
  11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205803

Locations
United States, New York
New York, New York, United States, 10045
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00205803     History of Changes
Other Study ID Numbers: 6096A1-003
Study First Received: September 19, 2005
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Infant Vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014