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Trial record 1 of 1 for:    B1971057
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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.

This study is currently recruiting participants.
Verified September 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT03135834
First Posted: May 1, 2017
Last Update Posted: September 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal pentavalent vaccine.

Condition Intervention Phase
Meningococcal Vaccine Biological: MenABCWY Biological: Saline Biological: rLP2086 Biological: MenACWY-CRM Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary MnB Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary MnB Strains Combined) for Groups 2 + 4 [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Assess B response after two doses of Trumenba

  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 7 Days after first vaccination ]
    Describe local reactions after first dose of Trumenba

  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 7 Days after second vaccination ]
    Describe local reactions after second dose of Trumenba.

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 7 Days after first vaccination ]
    Describe systemic events and use of anti-pyretic medication after first dose of Trumenba.

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 7 Days after second vaccination ]
    Describe systemic events and use of anti-pyretic medication after second dose of Trumenba.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after first vaccination ]
    Describe SAE frequency after first dose of Trumenba.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after second vaccination ]
    Describe SAE frequency after second dose of Trumenba.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after any vaccination in Stage 1 ]
    Describe SAE frequency after any dose of Trumenba in Stage 1.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Stage 1 Vaccination Phase for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe SAE frequency during the Stage 1 vaccination phase in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Stage 1 Follow-up Phase for Groups 2 and 4 combined [ Time Frame: From 1 month after second vaccination up to 6 months after the second vaccination ]
    Describe SAE frequency during the Stage 1 follow-up phase in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout Stage 1 of the Study for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 6 months after the second vaccination ]
    Describe SAE frequency during the Stage 1 in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after first vaccination ]
    Describe MAE frequency after first dose of Trumenba.

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after second vaccination ]
    Describe MAE frequency after second dose of Trumenba.

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after any vaccination ]
    Describe MAE frequency after any dose of Trumenba in Stage 1.

  • Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe MAE frequency during the Stage 1 vaccination phase in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase for Groups 2 and 4 combined [ Time Frame: From 1 month after second vaccination up to 6 months after the second vaccination ]
    Describe MAE frequency during the Stage 1 follow-up phase in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Medically Attended AE Throughout Stage 1 of the Study for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 6 months after the second vaccination ]
    Describe MAE frequency during the Stage 1 in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after first vaccination ]
    Describe NDCMC frequency after first dose of Trumenba.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after second vaccination ]
    Describe NDCMC frequency after second dose of Trumenba.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after any vaccination ]
    Describe NDCMC frequency after any dose of Trumenba in Stage 1

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Stage 1 Vaccination Phase for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe NDCMC frequency during the Stage 1 vaccination phase in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Stage 1 Follow-up Phase for Groups 2 and 4 combined [ Time Frame: From 1 month after second vaccination up to 6 months after the second vaccination ]
    Describe NDCMC frequency during the Stage 1 follow-up phase in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout Stage 1 of the Study for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 6 months after the second vaccination ]
    Describe NDCMC frequency during the Stage 1 in the Trumenba vaccination groups.

  • Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after first vaccination ]
    Describe AE frequency after first dose of Trumenba.

  • Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after second vaccination ]
    Describe AE frequency after second dose of Trumenba.

  • Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 days after any vaccination ]
    Describe AE frequency after any dose of Trumenba in Stage 1

  • Percentage of Participants With at Least 1 Adverse Event (AE) During the Stage 1 Vaccination Phase for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe AE frequency during the Stage 1 vaccination phase in the Trumenba vaccination groups.

  • Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 minutes after first vaccination ]
    Describe immediate AE frequency after first dose of Trumenba.

  • Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination for Groups 2 and 4 combined [ Time Frame: Within 30 minutes after second vaccination ]
    Describe immediate AE frequency after second dose of Trumenba.

  • Number of Days Participants Missed School or Work Due to AE During the Stage 1 Vaccination Phase for Groups 2 and 4 combined [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe the number of days missed from school or work due to an AE during the Stage 1 vaccination phase in Trumenba vaccination groups.


Secondary Outcome Measures:
  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary MenB Test Strains Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination: Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba.

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary MenB Test Strains Before the First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba.

  • hSBA Geometric Mean Titers (GMTs) for 4 Primary MenB Test Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba.

  • Percentage of Participants With hSBA Titers >= LLOQ for 10 Secondary MenB Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response (secondary strains) after two doses of Trumenba.

  • Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary MenB Strains Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination: Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response (secondary strains) after two doses of Trumenba.

  • GMTs for Each of the 10 Secondary MenB Strains Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination: Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response (secondary strains) after two doses of Trumenba.

  • Percentage of Participants With hSBA Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains 1 Month After the First Vaccination: Groups 1, 2, 3 and 4 [ Time Frame: 1 Month after Vaccination 1 ]
    Describe ACWY response after 1 dose of MenACWY-CRM compared to 1 dose of MenABCWY

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for ACWY Test Strains 1 Month After First Vaccination: Groups 1, 2, 3 and 4 [ Time Frame: 1 Month after Vaccination 1 ]
    Describe ACWY response after 1 dose of MenACWY-CRM compared to 1 dose of MenABCWY

  • hSBA GMTs for ACWY Test Strains 1 Month After First Vaccination: Groups 1, 2, 3 and 4 [ Time Frame: 1 Month after Vaccination 1 ]
    Describe ACWY response after 1 dose of MenACWY-CRM compared to 1 dose of MenABCWY

  • Percentage of Participants With hSBA Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains 1 Month After the First Vaccination in Groups 2 and 4, and 1 Month After Second Vaccination in Groups 1 and 3 [ Time Frame: 1 Month after Vaccination 1 (Groups 2 and 4), and 1 Month after Vaccination 2 (Groups 1 and 3) ]
    Describe ACWY response after 1 dose of MenACWY-CRM compared to 2 doses of MenABCWY

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for ACWY Test Strains 1 Month After the First Vaccination in Groups 2 and 4, and 1 Month After Second Vaccination in Groups 1 and 3 [ Time Frame: 1 Month after Vaccination 1 (Groups 2 and 4), and 1 Month after Vaccination 2 (Groups 1 and 3) ]
    Describe ACWY response after 1 dose of MenACWY-CRM compared to 2 doses of MenABCWY

  • hSBA GMTs for ACWY Test Strains 1 Month After the First Vaccination in Groups 2 and 4, and 1 Month After Second Vaccination in Groups 1 and 3 [ Time Frame: 1 Month after Vaccination 1 (Groups 2 and 4), and 1 Month after Vaccination 2 (Groups 1 and 3) ]
    Describe ACWY response after 1 dose of MenACWY-CRM compared to 2 doses of MenABCWY

  • Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MnB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MnB Strains Combined) for Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba compared to two doses of MenABCWY

  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary MenB Test Strains Before First Vaccination and 1 Month After the Second Vaccination: Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba compared to two doses of MenABCWY

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary MenB Test Strains Before the First Vaccination and 1 Month After Second Vaccination: Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba compared to two doses of MenABCWY

  • hSBA GMTs for 4 Primary MenB Test Strains Before First Vaccination and 1 Month After Second Vaccination: Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1 and 1 Month after Vaccination 2 ]
    Describe B response after two doses of Trumenba compared to two doses of MenABCWY

  • Percentage of Participants With hSBA Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains: Groups 1, 2, 3 and 4 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1, Before Vaccination 2, 1 Month after Vaccination 2 ]
    Describe ACWY response during Stage 1.

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for ACWY Test Strains: Groups 1, 2, 3 and 4 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1, Before Vaccination 2, 1 Month after Vaccination 2 ]
    Describe ACWY response during Stage 1.

  • hSBA GMTs for ACWY Test Strains: Groups 1, 2, 3 and 4 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1, Before Vaccination 2, 1 Month after Vaccination 2 ]
    Describe ACWY response during Stage 1.

  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary MenB Test Strains: Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1, Before Vaccination 2, 1 Month after Vaccination 2 ]
    Describe B response during Stage 1.

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary MenB Test Strains: Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1, Before Vaccination 2, 1 Month after Vaccination 2 ]
    Describe B response during Stage 1.

  • hSBA GMTs for 4 Primary MenB Test Strains: Groups 1 and 3 combined, and Groups 2 and 4 combined [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 1, Before Vaccination 2, 1 Month after Vaccination 2 ]
    Describe B response during Stage 1.

  • Percentage of Participants With hSBA Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains: Groups 1 and 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 2, at Month 18, 30, and 42, and Before the Booster vaccination ]
    Describe ACWY response during Stage 2 (Persistence)

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for ACWY Test Strains: Groups 1 and 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 2, at Month 18, 30, and 42, and Before the Booster vaccination ]
    Describe ACWY response during Stage 2 (Persistence)

  • hSBA GMTs for ACWY Test Strains: Groups 1 and 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 2, at Month 18, 30, and 42, and Before the Booster vaccination ]
    Describe ACWY response during Stage 2 (Persistence)

  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary MenB Test Strains: Group 1 and 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 2, at Month 18, 30, and 42, and Before the Booster vaccination ]
    Describe B response during Stage 2 (Persistence)

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary MenB Test Strains: Groups 1 and 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 2, at Month 18, 30, and 42, and Before the Booster vaccination ]
    Describe B response during Stage 2 (Persistence)

  • hSBA GMTs for 4 Primary MenB Test Strains: Groups 1 and 2 [ Time Frame: Before Vaccination 1, 1 Month after Vaccination 2, at Month 18, 30, and 42, and Before the Booster vaccination ]
    Describe B response during Stage 2 (Persistence)

  • Percentage of Participants With hSBA Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains: Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe ACWY response after MenABCWY booster

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for ACWY Test Strains: Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe ACWY response after MenABCWY booster

  • hSBA GMTs for ACWY Test Strains: Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe ACWY response after MenABCWY booster

  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary MenB Test Strains: Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after MenABCWY booster

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary MenB Test Strains: Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after MenABCWY booster

  • hSBA GMTs for 4 Primary MenB Test Strains: Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after MenABCWY booster

  • Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MnB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MnB Strains Combined) for Group 1 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after MenABCWY booster

  • Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary MenB Test Strains: Group 2 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after Trumenba booster

  • Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary MenB Test Strains: Group 2 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after Trumenba booster

  • hSBA GMTs for 4 Primary MenB Test Strains: Group 2 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after Trumenba booster

  • Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MnB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MnB Strains Combined) for Group 2 [ Time Frame: 1 Month after Vaccination 2, Before the Booster vaccination, and 1 Month after the Booster Vaccination ]
    Describe B response after Trumenba booster

  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination for Groups 1 and 3 [ Time Frame: Within 7 Days after first vaccination ]
    Describe local reactions after first dose of MenABCWY

  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 7 Days after second vaccination ]
    Describe local reactions after second dose of MenABCWY

  • Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 7 Days after booster vaccination ]
    Describe local reactions after booster

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination for Groups 1 and 3 [ Time Frame: Within 7 Days of the first vaccination ]
    Describe systemic events and use of anti-pyretic medication after first dose of MenABCWY.

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 7 Days of the second vaccination ]
    Describe systemic events and use of anti-pyretic medication after second dose of MenABCWY.

  • Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 7 Days of the booster vaccination ]
    Describe systemic events and use of anti-pyretic medication after booster.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after first vaccination ]
    Describe SAE frequency after first dose of MenABCWY.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after second vaccination ]
    Describe SAE frequency after second dose of MenABCWY.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 30 days after booster vaccination ]
    Describe SAE frequency after booster.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Stage 1 Vaccination Phase for Groups 1 and 3 [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe SAE frequency during the Stage 1 vaccination phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Stage 1 Follow-up Phase for Groups 1 and 3 [ Time Frame: From 1 month after second vaccination up to 6 months after the second vaccination ]
    Describe SAE frequency during the Stage 1 follow-up phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout Stage 1 of the Study for Groups 1 and 3 [ Time Frame: From the first vaccination up to 6 months after the second vaccination ]
    Describe SAE frequency during the Stage 1 in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Booster Vaccination Phase for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 1 month after the booster vaccination ]
    Describe SAE frequency during the Booster vaccination phase.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Booster Follow-up Phase for Groups 1 and 2 [ Time Frame: From 1 month after booster vaccination up to 6 months after the booster vaccination ]
    Describe SAE frequency during the Booster follow-up phase.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) from the booster vaccination to 6 months after the booster vaccination for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 6 months after the booster vaccination ]
    Describe SAE frequency following the Booster.

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after first vaccination ]
    Describe MAE frequency after first dose of MenABCWY.

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after second vaccination ]
    Describe MAE frequency after second dose of MenABCWY.

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 30 days after booster vaccination ]
    Describe MAE frequency after booster

  • Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after any vaccination in Stage 1 ]
    Describe MAE frequency after any dose of MenABCWY in Stage 1

  • Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase for Groups 1 and 3 [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe MAE frequency during the Stage 1 vaccination phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase for Groups 1 and 3 [ Time Frame: From 1 month after second vaccination up to 6 months after the second vaccination ]
    Describe MAE frequency during the Stage 1 follow-up phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Medically Attended AE Throughout Stage 1 of the Study for Groups 1 and 3 [ Time Frame: From the first vaccination up to 6 months after the second vaccination ]
    Describe MAE frequency during the Stage 1 in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Medically Attended AE During the Booster Vaccination Phase for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 1 month after the booster vaccination ]
    Describe MAE frequency during the Booster vaccination phase.

  • Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase for Groups 1 and 2 [ Time Frame: From 1 month after booster vaccination up to 6 months after the booster vaccination ]
    Describe MAE frequency during the Booster follow-up phase.

  • Percentage of Participants With at Least 1 Medically Attended AE from the booster vaccination to 6 months after the booster vaccination for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 6 months after the booster vaccination ]
    Describe MAE frequency following the Booster.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after first vaccination ]
    Describe NDCMC frequency after first dose of MenABCWY.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after second vaccination ]
    Describe NDCMC frequency after second dose of MenABCWY.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 30 days after booster vaccination ]
    Describe NDCMC frequency after booster

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after any vaccination in Stage 1 ]
    Describe NDCMC frequency after any dose of MenABCWY in Stage 1

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Stage 1 Vaccination Phase for Groups 1 and 3 [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe NDCMC frequency during the Stage 1 vaccination phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Stage 1 Follow-up Phase for Groups 1 and 3 [ Time Frame: From 1 month after second vaccination up to 6 months after the second vaccination ]
    Describe NDCMC frequency during the Stage 1 follow-up phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout Stage 1 of the Study for Groups 1 and 3 [ Time Frame: From the first vaccination up to 6 months after the second vaccination ]
    Describe NDCMC frequency during the Stage 1 in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Booster Vaccination Phase for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 1 month after the booster vaccination ]
    Describe NDCMC frequency during the Booster vaccination phase.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Booster Follow-up Phase for Groups 1 and 2 [ Time Frame: From 1 month after booster vaccination up to 6 months after the booster vaccination ]
    Describe NDCMC frequency during the Booster follow-up phase.

  • Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition from the booster vaccination to 6 months after the booster vaccination for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 6 months after the booster vaccination ]
    Describe NDCMC frequency during the Stage 1 in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 AE Within 30 Days After First Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after first vaccination ]
    Describe AE frequency after first dose of MenABCWY.

  • Percentage of Participants With at Least 1 AE Within 30 Days After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after second vaccination ]
    Describe AE frequency after second dose of MenABCWY.

  • Percentage of Participants With at Least 1 AE Within 30 Days After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 30 days after booster vaccination ]
    Describe AE frequency after booster

  • Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after any vaccination in Stage 1 ]
    Describe AE frequency after any dose of MenABCWY in Stage 1

  • Percentage of Participants With at Least 1 AE Durng the Stage 1 Vaccination Phase for Groups 1 and 3 [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe AE frequency during the Stage 1 vaccination phase in the MenABCWY vaccination groups.

  • Percentage of Participants With at Least 1 AE During the Booster Vaccination Phase for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 1 month after the booster vaccination ]
    Describe AE frequency during the Booster vaccination phase.

  • Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination for Groups 1 and 3 [ Time Frame: Within 30 minutes after first vaccination ]
    Describe immediate AE frequency after first dose of MenABCWY.

  • Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination for Groups 1 and 3 [ Time Frame: Within 30 minutes after second vaccination ]
    Describe immediate AE frequency after second dose of MenABCWY.

  • Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Booster Vaccination for Groups 1 and 2 [ Time Frame: Within 30 minutes after booster vaccination ]
    Describe immediate AE frequency after MenABCWY booster.

  • Number of Days Participants Missed School or Work Due to AE During the Stage 1 Vaccination Phase for Groups 1 and 3 [ Time Frame: From the first vaccination up to 1 month after the second vaccination ]
    Describe the number of days missed from school or work due to an AE during the Stage 1 vaccination phase in MenABCWY vaccination groups.

  • Number of Days Participants Missed School or Work Due to AE During the Booster Vaccination Phase for Groups 1 and 2 [ Time Frame: From the booster vaccination up to 1 month after the booster vaccination ]
    Describe the number of days missed from school or work due to an AE during the booster vaccination phase.

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination for Groups 1 and 3 [ Time Frame: Within 30 days after any vaccination in Stage 1 ]
    Describe SAE frequency after any MenABCWY dose in Stage 1.


Estimated Enrollment: 1590
Actual Study Start Date: April 24, 2017
Estimated Study Completion Date: January 25, 2023
Estimated Primary Completion Date: January 6, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (ACWY Naive subjects, MenABCWY/Saline)
ACWY Naive subjects, MenABCWY/Saline
Biological: MenABCWY
N meningitidis group A, B, C, W, and Y vaccine
Biological: Saline
Placebo
Experimental: Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)
ACWY Naive subjects, rLP2086/MenACWY-CRM
Biological: rLP2086
Bivalent recombinant lipoprotein 2086 vaccine
Biological: MenACWY-CRM
meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: Group 3 (ACWY Experienced subjects, MenABCWY/Saline)
ACWY Experienced subjects, MenABCWY/Saline
Biological: MenABCWY
N meningitidis group A, B, C, W, and Y vaccine
Biological: Saline
Placebo
Experimental: Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)
ACWY Experienced subjects, rLP2086/MenACWY-CRM
Biological: rLP2086
Bivalent recombinant lipoprotein 2086 vaccine
Biological: MenACWY-CRM
meningococcal group A, C, W-135, and Y conjugate vaccine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 polysaccaride (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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135834


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 68 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03135834     History of Changes
Other Study ID Numbers: B1971057
2016-004421-17 ( EudraCT Number )
First Submitted: April 26, 2017
First Posted: May 1, 2017
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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