Trial Outcomes & Findings for Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B (NCT NCT01362517)

NCT ID: NCT01362517

Last Updated: 2013-09-09

Results Overview

Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 131 participants
• Primary outcome timeframe: at 5 months (equivalent to 1 month after the third vaccination)
• Results posted on: 2013-09-09

Participant Flow

Participants were recruited at one center in Vietnam First subject first visit (FSFV): April 2010 Last subject last visit (LSLV): April 2011

Participant milestones

Measure	Quinvaxem Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age
Overall Study STARTED	131
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Quinvaxem Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

Baseline characteristics by cohort

Measure	Quinvaxem n=131 Participants Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at 2, 3 and 4 months of age
Age, Categorical <=18 years	131 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 5 months (equivalent to 1 month after the third vaccination)

Population: Analysis population excludes one subject excluded as a protocol violator

Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

Outcome measures

Measure	Quinvaxem n=130 Participants
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-diphtheria >=0.1 IU/mL	93.1 percentage of subjects Interval 87.3 to 96.8
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-pertussis >=20 EU/mL	99.2 percentage of subjects Interval 95.8 to 100.0
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-tetanus >=0.1 IU/mL	98.5 percentage of subjects Interval 94.6 to 99.8
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-hepatitis B >=10 mIU/mL	93.1 percentage of subjects Interval 87.3 to 96.8
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-PRP>=0.15 mcg/mL	100 percentage of subjects Interval 97.2 to 100.0

PRIMARY outcome

Timeframe: at 14 months (equivalent to 12 months after the first vaccination

Population: Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up

Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)

Outcome measures

Measure	Quinvaxem n=129 Participants
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-diphtheria >=0.1 IU/mL	88.4 percentage of subjects Interval 81.5 to 93.3
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-pertussis >=20 EU/mL	49.6 percentage of subjects Interval 40.7 to 58.5
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-tetanus >=0.1 IU/mL	82.2 percentage of subjects Interval 74.5 to 88.3
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-hepatitis B >=10 mIU/mL	76.7 percentage of subjects Interval 68.5 to 83.7
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component % of subjects with anti-PRP >=0.15 mcg/mL	97.7 percentage of subjects Interval 93.4 to 99.5

SECONDARY outcome

Timeframe: From Day 1 up to 30 days after the third vaccination

Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection

Outcome measures

Measure	Quinvaxem n=392 Doses
Safety: Adverse and Serious Adverse Events Injection site swelling	5.6 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Injection site redness	2.8 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Injection site pain	4.1 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Fever (>=38 deg C)	18.4 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Rash	0.3 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Loss of appetite	2.6 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Vomiting	1.0 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Diarrhea	3.0 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Irritability	7.9 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Abnormal crying	0 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Persistent crying	0.5 Number of children with AE per 100 doses
Safety: Adverse and Serious Adverse Events Drowsiness	0.5 Number of children with AE per 100 doses

Adverse Events

First Dose

Serious events: 4 serious events

Other events: 75 other events

Deaths: 0 deaths

Second Dose

Serious events: 6 serious events

Other events: 34 other events

Deaths: 0 deaths

Third Dose

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	First Dose n=131 participants at risk Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose given at 2 months of age	Second Dose n=131 participants at risk Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose given at 3 months of age	Third Dose n=130 participants at risk Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose given at 4 months of age
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	1.5% 2/131 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary infection	0.76% 1/131 • Number of events 1 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	1.5% 2/131 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.77% 1/130 • Number of events 1 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Gastrointestinal disorders Diarrhea	0.76% 1/131 • Number of events 1 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.76% 1/131 • Number of events 1 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Infections and infestations Viral infection	0.76% 1/131 • Number of events 1 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	1.5% 2/131 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.

Other adverse events

Measure	First Dose n=131 participants at risk Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose given at 2 months of age	Second Dose n=131 participants at risk Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose given at 3 months of age	Third Dose n=130 participants at risk Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose given at 4 months of age
General disorders Pyrexia	26.0% 34/131 • Number of events 34 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	15.3% 20/131 • Number of events 20 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	13.8% 18/130 • Number of events 18 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Metabolism and nutrition disorders Feeding disorder	7.6% 10/131 • Number of events 10 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Gastrointestinal disorders Vomiting	3.1% 4/131 • Number of events 4 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Gastrointestinal disorders Diarrhea	3.1% 4/131 • Number of events 4 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	2.3% 3/131 • Number of events 3 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	3.8% 5/130 • Number of events 5 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Psychiatric disorders Irritability	16.0% 21/131 • Number of events 21 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	6.1% 8/131 • Number of events 8 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	1.5% 2/130 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
General disorders Injection site induration	14.5% 19/131 • Number of events 19 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	2.3% 3/131 • Number of events 3 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
General disorders Injection site erythema	5.3% 7/131 • Number of events 7 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	1.5% 2/131 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	1.5% 2/130 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
General disorders Injection site pain	18.3% 24/131 • Number of events 24 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Skin and subcutaneous tissue disorders Rash	0.76% 1/131 • Number of events 1 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
Nervous system disorders Somnolence	1.5% 2/131 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
General disorders Persistent crying	1.5% 2/131 • Number of events 2 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/131 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.	0.00% 0/130 • Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319806111

Email: info@crucell.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator to submit all manuscripts/abstracts to the sponsor for review at least 60 days prior to any intended submission.
• Publication restrictions are in place

Restriction type: OTHER