Trial Outcomes & Findings for Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED) (NCT NCT00441012)
NCT ID: NCT00441012
Last Updated: 2015-03-19
Results Overview
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
COMPLETED
PHASE3
546 participants
11 months (1 month after the third dose)
2015-03-19
Participant Flow
06-Dec-2006 (First Participant Enrolled in Study) to 03-Jun-2008 (Last Participant had their Last Visit). This study was conducted at 27 sites: 17 in Canada (16 of which were active sites) and 10 in Finland.
Participants excluded for history of or prior vaccination for hepatitis B (Hep B) or Haemophilus influenzae Type B (Hib) disease and for administration of blood products. Participants also excluded if mother received Hep B, Hib vaccine, or blood products 6 months prior to participant birth.
Participant milestones
| Measure |
Modified Process Vaccine
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
276
|
|
Overall Study
Vaccination Visit 1
|
269
|
276
|
|
Overall Study
Vaccination Visit 2
|
267
|
272
|
|
Overall Study
Vaccination Visit 3
|
265
|
269
|
|
Overall Study
COMPLETED
|
252
|
263
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
Reasons for withdrawal
| Measure |
Modified Process Vaccine
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Protocol Violation
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Subject Randomized but Not Vaccinated
|
1
|
0
|
Baseline Characteristics
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Modified Process Vaccine
n=269 Participants
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270.
|
COMVAX™
n=276 Participants
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator.
|
Total
n=545 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 Days
n=5 Participants
|
68.3 Days
n=7 Participants
|
68.0 Days
n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11 months (1 month after the third dose)Population: Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
Outcome measures
| Measure |
Modified Process Vaccine
n=230 Participants
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
n=228 Participants
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
|
230 Participants
|
226 Participants
|
PRIMARY outcome
Timeframe: 11 months (1 month after the third dose)Population: Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
Outcome measures
| Measure |
Modified Process Vaccine
n=230 Participants
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
n=228 Participants
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
|
4204.4 mIU/mL
Interval 3411.2 to 5182.0
|
1683.4 mIU/mL
Interval 1350.4 to 2098.6
|
SECONDARY outcome
Timeframe: 0-11 months (recorded from first dose until the participant completes or discontinues)Population: Safety Analysis Set: The Safety Analysis Set is defined as all participants who receive at least one injection of vaccine and who had a safety follow-up.
Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)
Outcome measures
| Measure |
Modified Process Vaccine
n=269 Participants
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
n=273 Participants
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 11 months (1 month after the third dose)Population: Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.
The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
Outcome measures
| Measure |
Modified Process Vaccine
n=230 Participants
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
n=228 Participants
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
|
216 Participants
|
210 Participants
|
SECONDARY outcome
Timeframe: 11 months (1 month after the third dose)Population: Per-Protocol Population: The Per-Protocol Population is defined as the participants that were able to complete the study as defined by the protocol.
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
Outcome measures
| Measure |
Modified Process Vaccine
n=230 Participants
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
n=228 Participants
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
|
7.1 µg /mL
Interval 6.0 to 8.4
|
8.0 µg /mL
Interval 6.7 to 9.6
|
Adverse Events
Modified Process Vaccine
COMVAX™
Serious adverse events
| Measure |
Modified Process Vaccine
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/269
|
0.37%
1/273
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/269
|
0.37%
1/273
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/269
|
0.37%
1/273
|
Other adverse events
| Measure |
Modified Process Vaccine
Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
COMVAX™
COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
2.2%
6/269
|
2.9%
8/273
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
6/269
|
2.2%
6/273
|
|
Gastrointestinal disorders
Constipation
|
1.5%
4/269
|
2.2%
6/273
|
|
Gastrointestinal disorders
Diarrhea
|
8.9%
24/269
|
9.5%
26/273
|
|
Gastrointestinal disorders
Flatulence
|
3.0%
8/269
|
5.1%
14/273
|
|
Gastrointestinal disorders
Regurgitation
|
2.2%
6/269
|
4.0%
11/273
|
|
Gastrointestinal disorders
Teething
|
3.7%
10/269
|
6.2%
17/273
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
10/269
|
5.5%
15/273
|
|
General disorders
Fatigue
|
7.1%
19/269
|
5.5%
15/273
|
|
General disorders
Irritability
|
43.5%
117/269
|
48.0%
131/273
|
|
General disorders
Pyrexia
|
60.2%
162/269
|
61.2%
167/273
|
|
Infections and infestations
Ear infection
|
1.9%
5/269
|
1.1%
3/273
|
|
Infections and infestations
Exanthema subitum
|
1.1%
3/269
|
0.00%
0/273
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/269
|
1.1%
3/273
|
|
Infections and infestations
Influenza
|
3.0%
8/269
|
3.3%
9/273
|
|
Infections and infestations
Laryngitis
|
0.00%
0/269
|
1.5%
4/273
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
8/269
|
4.0%
11/273
|
|
Infections and infestations
Otitis media
|
4.5%
12/269
|
4.4%
12/273
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
3/269
|
0.73%
2/273
|
|
Infections and infestations
Rhinitis
|
9.3%
25/269
|
11.4%
31/273
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
16/269
|
4.8%
13/273
|
|
General disorders
Body temperature increased
|
2.2%
6/269
|
2.9%
8/273
|
|
Metabolism and nutrition disorders
Anorexia
|
5.2%
14/269
|
3.7%
10/273
|
|
Nervous system disorders
Poor quality sleep
|
1.5%
4/269
|
1.1%
3/273
|
|
Nervous system disorders
Somnolence
|
10.0%
27/269
|
11.4%
31/273
|
|
Psychiatric disorders
Crying
|
21.6%
58/269
|
23.1%
63/273
|
|
Psychiatric disorders
Insomnia
|
2.2%
6/269
|
1.5%
4/273
|
|
Psychiatric disorders
Restlessness
|
1.5%
4/269
|
5.5%
15/273
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
9/269
|
7.7%
21/273
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
6/269
|
2.9%
8/273
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.9%
5/269
|
1.5%
4/273
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.1%
3/269
|
0.73%
2/273
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.37%
1/269
|
1.5%
4/273
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
14/269
|
3.7%
10/273
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
3/269
|
0.37%
1/273
|
|
General disorders
Injection site bruising
|
3.3%
9/269
|
3.3%
9/273
|
|
General disorders
Injection site erythema
|
64.7%
174/269
|
65.6%
179/273
|
|
General disorders
Injection site hematoma
|
1.1%
3/269
|
0.37%
1/273
|
|
General disorders
Injection site induration
|
12.3%
33/269
|
11.4%
31/273
|
|
General disorders
Injection site nodule
|
2.2%
6/269
|
2.2%
6/273
|
|
General disorders
Injection site pain
|
72.5%
195/269
|
78.0%
213/273
|
|
General disorders
Injection site swelling
|
61.0%
164/269
|
53.5%
146/273
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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