Trial Outcomes & Findings for A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years. (NCT NCT01323270)

NCT ID: NCT01323270

Last Updated: 2022-10-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 753 participants
• Primary outcome timeframe: 1 month after Vaccination 1
• Results posted on: 2022-10-27

Participant Flow

A total of 753 participants were enrolled in this study. Of these, 4 participants were not randomized but were vaccinated rLP2086 vaccine or Repevax or Saline at Vaccination 1. These participants were included in safety population and not intent-to-treat population.

Participant milestones

Measure	Group 1: rLP2086 + Repevax Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Overall Study STARTED	373	376
Overall Study COMPLETED	330	347
Overall Study NOT COMPLETED	43	29

Reasons for withdrawal

Measure	Group 1: rLP2086 + Repevax Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Overall Study Withdrawal by Subject	19	10
Overall Study Protocol Violation	9	7
Overall Study Lost to Follow-up	4	6
Overall Study Adverse Event	8	0
Overall Study Other	0	3
Overall Study Physician Decision	0	2
Overall Study Not eligible	1	1
Overall Study Death	1	0
Overall Study Randomized, but not vaccinated	1	0

Baseline Characteristics

A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

Baseline characteristics by cohort

Measure	Group 1: rLP2086 + Repevax n=373 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=376 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.	Total n=749 Participants Total of all reporting groups
Age, Customized Greater than or equal (>=)11-less than (<)14years	217 participants n=5 Participants	215 participants n=7 Participants	432 participants n=5 Participants
Age, Customized >=14 years-<19 years	156 participants n=5 Participants	161 participants n=7 Participants	317 participants n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	184 Participants n=7 Participants	367 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants	192 Participants n=7 Participants	382 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after Vaccination 1

Outcome measures

Measure	Group 1: rLP2086 + Repevax n=337 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=348 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Diphtheria	99.4 percentage of participants	99.4 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Tetanus	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Pertussis toxoid	94.7 percentage of participants	96.0 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Pertussis filamentous hemagglutinin	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Pertussis pertactin	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Pertussis fimbrial agglutinogens types 2+3	97.6 percentage of participants	98.9 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Poliovirus type 1	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Poliovirus type 2	100.0 percentage of participants	100.0 percentage of participants
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen Poliovirus type 3	100.0 percentage of participants	100.0 percentage of participants

PRIMARY outcome

Timeframe: Vaccination 1 up to 1 month after Vaccination 3

Population: Summary was performed for participants as per vaccine administration.

Outcome measures

Measure	Group 1: rLP2086 + Repevax n=374 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=378 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Percentage of Participants With at Least One Adverse Event (AE)	37.4 percentage of participants	40.2 percentage of participants

SECONDARY outcome

Timeframe: 1 month after Vaccination 1

Outcome measures

Measure	Group 1: rLP2086 + Repevax n=337 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=348 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens Diphtheria	1.4 International Units per milliliter Interval 1.28 to 1.55	1.5 International Units per milliliter Interval 1.34 to 1.63
Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens Tetanus	12.3 International Units per milliliter Interval 11.5 to 13.11	12.4 International Units per milliliter Interval 11.52 to 13.25

SECONDARY outcome

Timeframe: 1 month after Vaccination 1

Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)

Outcome measures

Measure	Group 1: rLP2086 + Repevax n=337 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=348 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
GMC for Acellular Pertussis Antigens Pertussis filamentous hemagglutinin	119.4 EU/mL Interval 111.15 to 128.17	122.9 EU/mL Interval 115.14 to 131.13
GMC for Acellular Pertussis Antigens Pertussis fimbrial agglutinogens types 2+3	339.1 EU/mL Interval 296.35 to 387.94	364.5 EU/mL Interval 320.62 to 414.42
GMC for Acellular Pertussis Antigens Pertussis toxoid	27.1 EU/mL Interval 24.45 to 30.07	26.5 EU/mL Interval 23.95 to 29.38
GMC for Acellular Pertussis Antigens Pertussis pertactin	317.0 EU/mL Interval 285.64 to 351.8	336.1 EU/mL Interval 305.82 to 369.3

SECONDARY outcome

Timeframe: 1 month after Vaccination 1

Outcome measures

Measure	Group 1: rLP2086 + Repevax n=337 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=348 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Geometric Mean Titer (GMT) for Poliomyelitis Antigens Poliovirus type 1	662.1 titer Interval 567.36 to 772.67	672.6 titer Interval 581.87 to 777.55
Geometric Mean Titer (GMT) for Poliomyelitis Antigens Poliovirus type 2	840.5 titer Interval 725.11 to 974.29	995.8 titer Interval 860.54 to 1152.41
Geometric Mean Titer (GMT) for Poliomyelitis Antigens Poliovirus type 3	2237.4 titer Interval 1945.81 to 2572.65	2450.1 titer Interval 2152.6 to 2788.7

SECONDARY outcome

Timeframe: 1 month after Vaccination 3

Population: Serum samples from approximately 50% of the participants had hSBA performed with primary MnB test strains expressing rLP2086 variants A22 and B24 and the other 50% of participants had hSBAs performed with strains expressing variants A56 and B44. The number of participants shown for each test strain represents the number with valid and determinant assay result for that strain.

Outcome measures

Measure	Group 1: rLP2086 + Repevax n=307 Participants Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=330 Participants Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level PMB80 [A22] 1:16 (N=158, 166)	95.6 percentage of participants	19.9 percentage of participants
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level PMB2001 [A56] 1:8 (N=148, 152)	100.0 percentage of participants	26.3 percentage of participants
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level PMB2948 [B24] 1:8 (N=157, 170)	96.8 percentage of participants	12.9 percentage of participants
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level PMB2707 [B44] 1:8 (N=146, 159)	81.5 percentage of participants	8.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Before vaccination 1, 1 month after Vaccination 2, 3

Population: A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Before Vaccination 1, 1 month after Vaccination 2, 3

Population: A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.

Outcome measures

Outcome data not reported

Adverse Events

Group 1: rLP2086 + Repevax

Serious events: 12 serious events

Other events: 98 other events

Deaths: 0 deaths

Group 2: Saline+Repevax

Serious events: 9 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: rLP2086 + Repevax n=374 participants at risk Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=378 participants at risk Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Congenital, familial and genetic disorders Syndactyly	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Ear and labyrinth disorders Vertigo positional	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Appendicitis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.53% 2/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Abdominal abscess	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Appendicitis perforated	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Arthritis infective	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Cellulitis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Gastroenteritis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Peritonsillar abscess	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Sinusitis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Tonsillitis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Urinary tract infection	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Injury, poisoning and procedural complications Injury	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Injury, poisoning and procedural complications Road traffic accident	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Nervous system disorders Headache	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Nervous system disorders Hydrocephalus	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Nervous system disorders Syncope	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Psychiatric disorders Depression	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Psychiatric disorders Drug abuse	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.26% 1/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.

Other adverse events

Measure	Group 1: rLP2086 + Repevax n=374 participants at risk Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.	Group 2: Saline+Repevax n=378 participants at risk Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
Eye disorders Conjunctivitis	1.1% 4/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.79% 3/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Gastrointestinal disorders Diarrhoea	1.1% 4/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.79% 3/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Gastrointestinal disorders Nausea	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.1% 4/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
General disorders Pyrexia	1.3% 5/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.1% 4/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
General disorders Injection site pain	1.1% 4/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
General disorders Injection site swelling	1.1% 4/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.00% 0/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Nasopharyngitis	8.0% 30/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	8.2% 31/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Pharyngitis	4.5% 17/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	5.0% 19/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Upper respiratory tract infection	4.3% 16/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	5.0% 19/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Bronchitis	2.4% 9/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	4.8% 18/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Gastroenteritis	2.1% 8/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	2.9% 11/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Sinusitis	2.1% 8/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.6% 6/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Otitis media	0.80% 3/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.9% 7/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Acute tonsillitis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.9% 7/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Tonsillitis	0.27% 1/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.9% 7/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Infections and infestations Rhinitis	0.53% 2/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.1% 4/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Injury, poisoning and procedural complications Contusion	1.1% 4/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	0.79% 3/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Musculoskeletal and connective tissue disorders Back pain	1.6% 6/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.9% 7/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Nervous system disorders Headache	2.4% 9/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	2.4% 9/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.
Respiratory, thoracic and mediastinal disorders Cough	0.53% 2/374 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.	1.6% 6/378 • AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086/saline/Repevax). SAE reported from Vaccination 1 to 6 months after last of investigational product (bivalent rLP2086/saline/Repevax). Events collected on case report form were reported. Summary was performed for participants as per vaccine administration.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER