April 11, 2018
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April 30, 2018
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February 8, 2021
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March 2, 2021
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March 2, 2021
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April 16, 2018
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February 11, 2020 (Final data collection date for primary outcome measure)
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- 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.
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- 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.
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- 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.
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Not Provided
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Not Provided
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Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
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A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
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A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
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NOTE: Detailed description has not been entered.
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Interventional
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Phase 2
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention
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Pneumococcal Infections
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- Biological: Multivalent
Pneumococcal conjugate vaccine
Other Name: Pneumococcal conjugate vaccine
- Biological: 13vPnC
Pneumococcal conjugate vaccine
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- Experimental: Multivalent
Pneumococcal conjugate vaccines
Intervention: Biological: Multivalent
- Active Comparator: Control
13vPnC
Intervention: Biological: 13vPnC
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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.
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Completed
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460
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Same as current
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February 11, 2020
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February 11, 2020 (Final data collection date for primary outcome measure)
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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
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Sexes Eligible for Study: |
All |
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42 Days to 98 Days (Child)
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Yes
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Contact information is only displayed when the study is recruiting subjects
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United States
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NCT03512288
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B7471003
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Yes
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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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 |
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Pfizer
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Same as current
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Pfizer
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Same as current
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Not Provided
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Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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Pfizer
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February 2021
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