Trial Outcomes & Findings for A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) (NCT NCT00414050)

Last Updated: 2017-05-23

Results Overview

The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1718 participants

Primary outcome timeframe

7 months of age (1 month after 3 doses)

Results posted on

2017-05-23

Participant Flow

15-Nov-2006 (First Participant Enrolled in Study) to 24-Oct-2007 (Last Participant had their Last Visit). Last participant completed follow-up: 16-Oct-2007.This study was conducted at 15 sites; 14 in Finland and 1 in Norway.

Participant milestones

Participant milestones
Measure	Modified Process Hepatitis B Vaccine 5 µg (Micrograms) Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.	RECOMBIVAX™ Hepatitis B Vaccine Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.	Modified Process Hepatitis B Vaccine 10 µg Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.	ENGERIX-B® Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Overall Study STARTED	431	427	429	431
Overall Study Received Vaccination 1	431	426	429	431
Overall Study Received Vaccination 2	425	421	425	425
Overall Study Received Vaccination 3	424	419	425	424
Overall Study COMPLETED	422	419	423	423
Overall Study NOT COMPLETED	9	8	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Modified Process Hepatitis B Vaccine 5 µg (Micrograms) Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.	RECOMBIVAX™ Hepatitis B Vaccine Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.	Modified Process Hepatitis B Vaccine 10 µg Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.	ENGERIX-B® Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Overall Study Adverse Event	1	1	1	1
Overall Study Lost to Follow-up	2	2	1	1
Overall Study Withdrawal by Subject	5	3	2	4
Overall Study Subject discontinued for other reason	1	2	2	1
Overall Study Subject Moved	0	0	0	1

Baseline Characteristics

A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Process Hepatitis B Vaccine 5 µg (Micrograms) n=431 Participants Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.	RECOMBIVAX™ Hepatitis B Vaccine n=427 Participants Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.	Modified Process Hepatitis B Vaccine 10 µg n=429 Participants Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.	ENGERIX-B® n=431 Participants Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.	Total n=1718 Participants Total of all reporting groups
Age, Continuous	63.2 days STANDARD_DEVIATION 10.18 • n=5 Participants	62.9 days STANDARD_DEVIATION 10.15 • n=7 Participants	63.3 days STANDARD_DEVIATION 9.83 • n=5 Participants	62.8 days STANDARD_DEVIATION 9.81 • n=4 Participants	63.1 days STANDARD_DEVIATION 9.99 • n=21 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	217 Participants n=7 Participants	208 Participants n=5 Participants	201 Participants n=4 Participants	816 Participants n=21 Participants
Sex: Female, Male Male	241 Participants n=5 Participants	210 Participants n=7 Participants	221 Participants n=5 Participants	230 Participants n=4 Participants	902 Participants n=21 Participants

PRIMARY outcome

Timeframe: 7 months of age (1 month after 3 doses)

Population: Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.

Outcome measures

Outcome measures
Measure	Modified Process Hepatitis B Vaccine 5 µg (Micrograms) n=405 Participants Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.	RECOMBIVAX™ Hepatitis B Vaccine n=406 Participants Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.	Modified Process Hepatitis B Vaccine 10 µg n=398 Participants Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.	ENGERIX-B® n=400 Participants Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®	99.3 Percentage of participants Interval 98.3 to 100.0	98.5 Percentage of participants Interval 97.2 to 99.8	100 Percentage of participants Interval 99.9 to 100.0	99.5 Percentage of participants Interval 98.7 to 100.0

SECONDARY outcome

Timeframe: 7 months of age (1 month after 3 doses)

Population: Participants who follow the protocol, do not have major protocol deviations and have post-vaccination serology within specified day ranges.

Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.

Outcome measures

Outcome measures
Measure	Modified Process Hepatitis B Vaccine 5 µg (Micrograms) n=405 Participants Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.	RECOMBIVAX™ Hepatitis B Vaccine n=406 Participants Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.	Modified Process Hepatitis B Vaccine 10 µg n=398 Participants Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.	ENGERIX-B® n=400 Participants Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®	748.2 mIU/mL Interval 672.0 to 833.1	376.8 mIU/mL Interval 331.4 to 428.5	981.5 mIU/mL Interval 891.0 to 1081.2	556.6 mIU/mL Interval 491.8 to 629.9

Adverse Events

Modified Process Hepatitis B Vaccine 5 µg (Micrograms)

Serious events: 11 serious events

Other events: 308 other events

Deaths: 0 deaths

RECOMBIVAX™ Hepatitis B Vaccine

Serious events: 2 serious events

Other events: 294 other events

Deaths: 0 deaths

Modified Process Hepatitis B Vaccine 10 µg

Serious events: 6 serious events

Other events: 276 other events

Deaths: 0 deaths

ENGERIX-B®

Serious events: 8 serious events

Other events: 288 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Modified Process Hepatitis B Vaccine 5 µg (Micrograms) n=430 participants at risk Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.	RECOMBIVAX™ Hepatitis B Vaccine n=424 participants at risk Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.	Modified Process Hepatitis B Vaccine 10 µg n=429 participants at risk Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.	ENGERIX-B® n=428 participants at risk Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 21/430 • Number of events 21 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	3.5% 15/424 • Number of events 18 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	4.0% 17/429 • Number of events 19 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	5.8% 25/428 • Number of events 26 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
Eye disorders Conjunctivitis	2.1% 9/430 • Number of events 11 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	3.3% 14/424 • Number of events 14 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	2.3% 10/429 • Number of events 10 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	5.1% 22/428 • Number of events 23 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
General disorders Irritability	26.5% 114/430 • Number of events 169 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	25.7% 109/424 • Number of events 157 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	21.2% 91/429 • Number of events 138 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	25.0% 107/428 • Number of events 139 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
General disorders Pyrexia	14.4% 62/430 • Number of events 78 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	13.4% 57/424 • Number of events 65 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	13.1% 56/429 • Number of events 68 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	12.4% 53/428 • Number of events 65 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
General disorders Injection-site erythema	29.8% 128/430 • Number of events 169 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	27.6% 117/424 • Number of events 160 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	27.0% 116/429 • Number of events 153 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	22.0% 94/428 • Number of events 124 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
General disorders Injection-site pain	18.4% 79/430 • Number of events 117 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	17.2% 73/424 • Number of events 96 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	14.0% 60/429 • Number of events 90 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	15.4% 66/428 • Number of events 92 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
General disorders Injection-site induration	5.8% 25/430 • Number of events 29 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	3.5% 15/424 • Number of events 19 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	5.6% 24/429 • Number of events 26 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	1.9% 8/428 • Number of events 9 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
General disorders Injection-site swelling	18.1% 78/430 • Number of events 109 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	20.0% 85/424 • Number of events 111 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	20.3% 87/429 • Number of events 110 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	15.2% 65/428 • Number of events 98 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
Psychiatric disorders Crying	9.5% 41/430 • Number of events 51 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	9.2% 39/424 • Number of events 49 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	9.1% 39/429 • Number of events 48 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	9.6% 41/428 • Number of events 48 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
Gastrointestinal disorders Diarrhoea	7.0% 30/430 • Number of events 37 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	6.1% 26/424 • Number of events 36 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	6.1% 26/429 • Number of events 31 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	4.2% 18/428 • Number of events 26 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
Infections and infestations Upper respiratory tract infection	7.4% 32/430 • Number of events 35 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	6.1% 26/424 • Number of events 27 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	5.8% 25/429 • Number of events 25 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	5.4% 23/428 • Number of events 25 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.
Infections and infestations Rhinitis	12.3% 53/430 • Number of events 57 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	11.1% 47/424 • Number of events 54 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	13.8% 59/429 • Number of events 68 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.	11.9% 51/428 • Number of events 57 • Serious adverse events (SAEs): up to 5 months (entire study period); Systemic non-serious adverse events (NSAEs): up to 14 days after any vaccination; Injection-site NSAEs: up to 5 days after any vaccination All randomized participants with follow-up who received at least one dose of study vaccine. Below tables exclude one RECOMBIVAX HB participant who received 2 doses of RECOMBIVAX HB™ and 1 dose of modified process hepatitis B vaccine 10 μg, and one ENGERIX-B® participant who received 2 doses of ENGERIX-B® and 1 dose of RECOMBIVAX HB™.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1 800 672 6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER