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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 11, 2018
• First Posted Date: April 30, 2018
• Results First Submitted Date: February 8, 2021
• Results First Posted Date: March 2, 2021
• Last Update Posted Date: March 2, 2021
• Actual Study Start Date: April 16, 2018
• Actual Primary Completion Date: February 11, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Pneumococcal Infections

Intervention

• Biological: Multivalent
  Pneumococcal conjugate vaccine
  Other Name: Pneumococcal conjugate vaccine
• Biological: 13vPnC
  Pneumococcal conjugate vaccine

Study Arms

• Experimental: Multivalent
  Pneumococcal conjugate vaccines
  Intervention: Biological: Multivalent
• Active Comparator: Control
  13vPnC
  Intervention: Biological: 13vPnC

• Publications *: Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2018): 460
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 11, 2020
• Actual Primary Completion Date: February 11, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 42 Days to 98 Days (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03512288
• Other Study ID Numbers: 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

• 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

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2021