Clinical trial NCT03135834: A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Official title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 1610
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.


Eligibility criteria: Inclusion Criteria:

* Male or female subject aged \>=10 and \<26 years at the time of enrollment.
* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
* Negative urine pregnancy test for all female subjects.
* Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

Exclusion Criteria:

* Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
* Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Current chronic use of systemic antibiotics.
* Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Primary outcomes:
measure: Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 7 days after Vaccination 1
measure: Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 7 days after Vaccination 2
measure: Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 7 days after Vaccination 1
measure: Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 7 days after Vaccination 2
measure: Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 7 days after Vaccination 1
measure: Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 7 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
measure: Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)
timeFrame: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)
timeFrame: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
measure: Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined)
timeFrame: 30 days after any Vaccination
measure: Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
measure: Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)
timeFrame: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
measure: Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 30 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)
timeFrame: 30 minutes after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 30 minutes after Vaccination 2
measure: Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4
timeFrame: 7 days after booster vaccination
measure: Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4
timeFrame: 7 days after booster vaccination
measure: Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4
timeFrame: 7 days after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4
timeFrame: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4
timeFrame: Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)
measure: Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4
timeFrame: Throughout Booster phase: From booster vaccination through 6 months after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4
timeFrame: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4
timeFrame: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)
measure: Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4
timeFrame: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4
timeFrame: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4
timeFrame: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)
measure: Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4
timeFrame: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4
timeFrame: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
measure: Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4
timeFrame: 30 minutes after booster vaccination
measure: Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4
timeFrame: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
Secondary outcomes:
measure: Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2 (Vacc 2)
measure: Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2 (Vacc 2)
measure: Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2 (Vacc 2)
measure: Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2 (Vacc 2)
measure: Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2 (Vacc 2)
measure: Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4
timeFrame: 1 month after Vaccination 1
measure: Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4
timeFrame: 1 month after Vaccination 1
measure: Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4
timeFrame: 1 month after Vaccination 1
measure: Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3
timeFrame: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3
timeFrame: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
measure: Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3
timeFrame: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2 (Vacc 2)
measure: Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined)
timeFrame: Baseline to 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2
measure: Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: 1 month after Vaccination 2
measure: Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4
timeFrame: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
measure: Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4
timeFrame: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
measure: Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4
timeFrame: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
measure: Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
measure: Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
measure: Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]
measure: Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4
timeFrame: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)
measure: Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)
measure: Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)
timeFrame: 1 month after booster vaccination
measure: Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)
timeFrame: 1 month after booster vaccination
measure: Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 7 days after Vaccination 1 (Vacc 1)
measure: Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 7 days after Vaccination 2 (Vacc 2)
measure: Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 7 days after Vaccination 1 (Vacc 1)
measure: Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 7 days after Vaccination 2 (Vacc 2)
measure: Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 30 days after Vaccination 1
measure: Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 30 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 30 days after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 30 days after Vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3
timeFrame: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
measure: Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3
timeFrame: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 30 days after vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 30 days after vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3
timeFrame: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
measure: Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3
timeFrame: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
measure: Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 30 days after vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 30 days after vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3
timeFrame: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
measure: Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3
timeFrame: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
measure: Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3
timeFrame: 30 days after vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3
timeFrame: 30 days after vaccination 2
measure: Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3
timeFrame: 30 days after any vaccination
measure: Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
measure: Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3
timeFrame: 30 minutes after Vaccination 1
measure: Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3
timeFrame: 30 minutes after Vaccination 2
measure: Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3
timeFrame: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Huntsville
country: United States
facility: Optimal Research, LLC
state: Alabama
city: Fountain Hills
country: United States
facility: Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium
state: Arizona
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Melbourne
country: United States
facility: Optimal Research, LLC
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research LLC
state: Georgia
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance For Multispecialty Research (AMR)
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Eunice
country: United States
facility: Horizon Research Group of Opelousas, LLC
state: Louisiana
city: Haughton
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Binghamton
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Vestal
country: United States
facility: Regional Clinical Research, Inc
state: New York
city: Raleigh
country: United States
facility: Capitol Pediatrics & Adolescent Center PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Pediatrics, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Care, PLLC
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Plano
country: United States
facility: Acrc Trials
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Draper
country: United States
facility: J. Lewis Research Inc. / Foothill Family Clinic Draper
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Jindrichuv Hradec
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha 6
country: Czechia
facility: MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic
city: Järvenpää
country: Finland
facility: Jarvenpaa Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Seinajoki
country: Finland
facility: Seinajoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Debica
country: Poland
facility: Jerzy Brzostek Prywatny Gabinet Lekarski
city: Krakow
country: Poland
facility: Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska
city: Krakow
country: Poland
facility: Oddzial Pediatrii i Neurologii Dzieciecej, Krakowski Szpital Specjalistyczny im. Jana Pawla II
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: