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NCT Number: NCT01692886

A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.

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Key information

Conditions

Pneumococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

42 day–77 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jiangsu Province Guanyun County Center for Disease prevention and Control, Guanyun County,, Jiangsu, China

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
  • Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion criteria

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal vaccines.

Treatment and study plan

7-valent pneumococcal conjugate vaccine

Biological

suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

Other names: 7vPnC

13-valent Pnumococcal Conjugate vaccine

Biological

suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively

Other names: 13vPnC

Primary outcomes

  1. Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.

    Time frame: 1 month after the infant series (6 Months of age)

  2. Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.

    Time frame: 1 month after the infant series (7 Months of age)

  3. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.

    Time frame: 1 month after the infant series (6 Months of age)

  4. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.

    Time frame: 1 month after the infant series (7 Months of age)

  5. Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.

    Time frame: Approximately 16 months from the participation into the study to the end of study

  6. Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.

    Time frame: Approximately 16 months from the participation into study to the end of study

  7. Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.

    Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months

  8. Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.

    Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months

  9. Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.

    Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months

  10. Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.

    Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months

Secondary outcomes

  1. Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.

    Time frame: 1 month after the infant series (6 Months of age)

  2. Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.

    Time frame: 1 month after the infant series (7 Months of age)

  3. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.

    Time frame: 1 month after the infant series (6 Months of age)

  4. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.

    Time frame: 1 month after the infant series (7 Months of age)

  5. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.

    Time frame: 1 month after the toddler dose (13 Months of age)

  6. Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.

    Time frame: 1 month after the toddler dose (13 Months of age)

  7. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.

    Time frame: 1 month after the toddler dose (13 Months of age)

  8. Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.

    Time frame: 1 month after the infant series (6 Months of age)

  9. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.

    Time frame: 1 month after the infant series (6 Months of age)

  10. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.

    Time frame: 1 month after the toddler dose (13 Months of age)

  11. Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.

    Time frame: 1 month after the infant series (6 Months of age)

  12. Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.

    Time frame: 1 month after the toddler dose (13 Months of age)

  13. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.

    Time frame: 1 month after the infant series (6 Months of age)

  14. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.

    Time frame: 1 month after the toddler dose (13 Months of age)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 3, Randomized, Active-controlled, Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13vpnc Compared With A 7vpnc In Healthy Infants In China

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 25, 2012
Registry last updated
Jun 2, 2026

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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