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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384059
First received: October 2, 2006
Last updated: January 22, 2013
Last verified: January 2013

October 2, 2006
January 22, 2013
October 2006
October 2008   (final data collection date for primary outcome measure)
  • Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. [ Time Frame: One month after infant series dose 2 (5 months of age) ] [ Designated as safety issue: No ]
    Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.
  • Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series [ Time Frame: one month after infant series dose 2 (5 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series [ Time Frame: one month after infant series dose 2 (5 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series [ Time Frame: one month after infant series dose 2 (5 months of age) ] [ Designated as safety issue: No ]
  • Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose [ Time Frame: one month after infant series dose 2 (5 months of age), before and after toddler dose (12 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.
  • Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. [ Time Frame: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age) ] [ Designated as safety issue: No ]
    Antibody concentration/geometric mean concentration (GMC) as measured by 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 with corresponding 2-sided 95% CI.
To compare immunogenicity of 13vPnC to Prevenar using serotype-specific serum IgG antibody levels; to evaluate immunogenicity of antigens in concomitant vaccines; to assess safety by local injection site reaction and systemic events, and adverse events.
Complete list of historical versions of study NCT00384059 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. [ Time Frame: one month after the toddler dose (13 months of age) ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. [ Time Frame: one month after toddler dose (13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose. [ Time Frame: one month after toddler dose (13 months of age) ] [ Designated as safety issue: No ]
  • Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: one month after toddler dose (13 months of age) ] [ Designated as safety issue: No ]
Not Provided
  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (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 (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 ] [ Designated as safety issue: Yes ]
    Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.
Not Provided
 
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vaccines, Pneumococcal
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
  • Biological: 7vPnC
    Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
  • Biological: Pediacel
    concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
  • Biological: NeisVac-C
    concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
  • Biological: Menitorix
    concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
  • Experimental: 1
    13-valent pneumococcal vaccine
    Interventions:
    • Biological: 13-valent Pneumococcal Conjugate Vaccine
    • Biological: Pediacel
    • Biological: NeisVac-C
    • Biological: Menitorix
  • Active Comparator: 2
    7-valent pneumococcal vaccine
    Interventions:
    • Biological: 7vPnC
    • Biological: Pediacel
    • Biological: NeisVac-C
    • Biological: Menitorix

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged 2 months (42 to 98 days) at the time of enrollment.
  2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.
  8. Major known congenital malformation or serious chronic disorder.
  9. 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. This did not include resolving syndromes due to birth trauma such as Erb palsy.
  10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
  12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Both
42 Days to 98 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00384059
6096A1-007
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For UK/Great Britian, ukmedinfo@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP