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Completed

NCT Number: NCT00366340

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

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

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Key information

Conditions

Vaccines, Pneumococcal

Age range

56 day–112 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bad Kreuznach, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 2 months (56 to 112 days) at time of enrollment.
  • Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
  • Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
  • Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion criteria

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
  • 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 or H influenzae type b.
  • Major known congenital malformation or serious chronic disorder.
  • 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. Did not include resolving syndromes due to birth trauma such as Erb palsy.
  • Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  • Participation in another investigational trial. Participation in purely observational studies was acceptable.
  • Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

7-valent pneumococcal conjugate vaccine

Biological

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

Primary outcomes

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

    Time frame: One month after 3-dose infant series (5 months of age)

    Percentage of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.

  2. 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 (5 months of age)

    Antibody concentration/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.

  3. Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.

    Time frame: One month after 3-dose infant series (5 months of age)

    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.

  4. Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

    Time frame: One month after 3-dose infant series (5 months of age)

    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) are presented.

  5. Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

    Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

    Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).

  6. Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

    Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

  7. Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

    Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

  8. Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

    Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)

    Antibody geometric mean concentration (GMC) as measured by mcg/mL 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.

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

    Time frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)

    Antibody concentration/geometric mean concentration 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.

  10. Percentage of Participants Reporting Pre-Specified Local Reactions

    Time frame: Day 1 through 4 after each dose

    Local reactions were reported using an electronic diary. 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 (> 7.0 cm). Participants may be represented in more than 1 category.

  11. Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)

    Time frame: Day 1 through 4 after each dose

    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

  12. Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)

    Time frame: Day 1 through 4 after each dose

    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 21, 2006
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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