Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    B7471003
Previous Study | Return to List | Next Study

Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512288
Recruitment Status : Completed
First Posted : April 30, 2018
Results First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE April 30, 2018
Results First Submitted Date  ICMJE February 8, 2021
Results First Posted Date  ICMJE March 2, 2021
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE April 16, 2018
Actual Primary Completion Date February 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 [ Time Frame: Within 7 days after Vaccination 1 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
  • Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 [ Time Frame: Within 7 days after Vaccination 2 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
  • Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 [ Time Frame: Within 7 days after Vaccination 3 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
  • Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 [ Time Frame: Within 7 days after Vaccination 4 ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
  • Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 [ Time Frame: Within 7 days after Vaccination 1 ]
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
  • Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 [ Time Frame: Within 7 days after Vaccination 2 ]
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
  • Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 [ Time Frame: Within 7 days after Vaccination 3 ]
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
  • Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 [ Time Frame: Within 7 days after Vaccination 4 ]
    Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
  • Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 [ Time Frame: From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) ]
    An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.
  • Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 [ Time Frame: From Vaccination 4 to 1 month after Vaccination 4 ]
    An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.
  • Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 [ Time Frame: From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months) ]
    An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
  • Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 [ Time Frame: From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months) ]
    An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Percentage of subjects reporting prompted local reactions within 7 days after a dose (redness, swelling, and pain at the injection site) [ Time Frame: Day 7 ]
    Describe prompted local reactions after a dose.
  • Percentage of subjects reporting prompted systemic events within 7 days after a dose (fever, decreased appetite, irritability, and drowsiness/increased sleep). [ Time Frame: Day 7 ]
    Describe prompted systemic reactions after a dose.
  • Percentages of subjects reporting adverse events (AEs) occurring from Dose 1 to 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Describe adverse events occurring from Dose 1 to 1 month after Dose 3
  • Percentages of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) occurring from Dose 1 to 6 months following Dose 4. [ Time Frame: 6 months after Dose 4 ]
    Describe SAEs and NDCMCs occurring from Dose 1 to 6 months after Dose 4.
  • Percentages of subjects reporting adverse events (AEs) occurring from Dose 4 to 1 month after Dose 4. [ Time Frame: 1 month after Dose 4 ]
    Describe adverse events occurring from Dose 4 to 1 month after Dose 4.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3 [ Time Frame: 1 month after Vaccination 3 ]
    Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per milliliter, for serotype 5: >=0.23 microgram per milliliter, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per milliliter.
  • Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3 [ Time Frame: 1 month after Vaccination 3 ]
    IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
  • Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4 [ Time Frame: 1 Month after Vaccination 4 ]
    IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Pneumococcal serotype-specific IgG concentrations 1 month after Dose 3. [ Time Frame: 1 month after Dose 3 ]
    Describe IgG concentrations 1 month after Dose 3.
  • Pneumococcal serotype-specific IgG concentrations 1 month after Dose 4. [ Time Frame: 1 month after Dose 4 ]
    Describe IgG concentrations 1 month after Dose 4.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Official Title  ICMJE A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Brief Summary A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
Detailed Description NOTE: Detailed description has not been entered.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
    Other Name: Pneumococcal conjugate vaccine
  • Biological: 13vPnC
    Pneumococcal conjugate vaccine
Study Arms  ICMJE
  • Experimental: Multivalent
    Pneumococcal conjugate vaccines
    Intervention: Biological: Multivalent
  • Active Comparator: Control
    13vPnC
    Intervention: Biological: 13vPnC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
460
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 11, 2020
Actual Primary Completion Date February 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
  • Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
  • Previous receipt of >1 dose of hepatitis B vaccine.
  • Prior hepatitis B vaccine must have been administered at age <30 days.
  • Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03512288
Other Study ID Numbers  ICMJE B7471003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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