Trial Outcomes & Findings for Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination (NCT NCT01357720)

NCT ID: NCT01357720

Last Updated: 2013-09-09

Results Overview

Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 400 participants
• Primary outcome timeframe: 1 month after the third vaccination
• Results posted on: 2013-09-09

Participant Flow

Participants were recruited at two vaccination sites in the Philippines: First subject first visit (FSFV): 30 May 2011 Last subject last visit (LSLV): 30 September 2011

Participant milestones

Measure	Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Overall Study STARTED	200	200
Overall Study COMPLETED	198	195
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

Baseline characteristics by cohort

Measure	Quinvaxem n=200 Participants Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=200 Participants Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	200 Participants n=5 Participants	200 Participants n=7 Participants	400 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	6.8 weeks STANDARD_DEVIATION 0.91 • n=5 Participants	6.7 weeks STANDARD_DEVIATION 0.86 • n=7 Participants	6.7 weeks STANDARD_DEVIATION 0.89 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	105 Participants n=7 Participants	206 Participants n=5 Participants
Sex: Female, Male Male	99 Participants n=5 Participants	95 Participants n=7 Participants	194 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after the third vaccination

Population: Available observations at Visit 4

Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)

Outcome measures

Measure	Quinvaxem n=197 Participants Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=193 Participants Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Seroprotection Rate: Anti-PRP Antibodies	100 percentage of subjects Interval 98.1 to 100.0	100 percentage of subjects Interval 98.1 to 100.0

PRIMARY outcome

Timeframe: 1 month after the third vaccination

Population: Available observations at Visit 4

Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)

Outcome measures

Measure	Quinvaxem n=198 Participants Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=194 Participants Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Seroprotection Rate: Anti-hepatitis B Surface Antibodies	94.9 percentage of subjects Interval 90.9 to 97.6	97.4 percentage of subjects Interval 94.1 to 99.2

PRIMARY outcome

Timeframe: 1 month after the third vaccination

Population: Available observations at Visit 4

Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)

Outcome measures

Measure	Quinvaxem n=198 Participants Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=194 Participants Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies	99.5 percentage of subjects Interval 97.2 to 100.0	100 percentage of subjects Interval 98.1 to 100.0

PRIMARY outcome

Timeframe: 1 month after the third vaccination

Population: Available observations at Visit 4

Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)

Outcome measures

Measure	Quinvaxem n=198 Participants Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=194 Participants Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Seroprotection Rate: Anti-tetanus Toxoid Antibodies	100 percentage of subjects Interval 98.2 to 100.0	100 percentage of subjects Interval 98.1 to 100.0

PRIMARY outcome

Timeframe: 1 month after the third vaccination

Population: Available observations at Visit 4

Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)

Outcome measures

Measure	Quinvaxem n=198 Participants Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=194 Participants Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Seroprotection Rate: Anti-B. Pertussis Antibodies	99.0 percentage of subjects Interval 96.4 to 99.9	100 percentage of subjects Interval 98.1 to 100.0

Adverse Events

Quinvaxem

Serious events: 0 serious events

Other events: 180 other events

Deaths: 0 deaths

Tritanrix Hib/HepB + Quinvaxem

Serious events: 2 serious events

Other events: 180 other events

Deaths: 0 deaths

Serious adverse events

Measure	Quinvaxem n=200 participants at risk Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=200 participants at risk Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
Infections and infestations Viral encephalitis	0.00% 0/200 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	0.50% 1/200 • Number of events 1 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/200 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	0.50% 1/200 • Number of events 1 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Infections and infestations Pneumonia	0.00% 0/200 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	0.50% 1/200 • Number of events 1 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/200 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	0.50% 1/200 • Number of events 1 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.

Other adverse events

Measure	Quinvaxem n=200 participants at risk Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem	Tritanrix Hib/HepB + Quinvaxem n=200 participants at risk Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
General disorders Injection site pain	68.5% 137/200 • Number of events 293 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	78.5% 157/200 • Number of events 338 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
General disorders Injection site induration	37.0% 74/200 • Number of events 138 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	41.0% 82/200 • Number of events 145 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
General disorders Injection site erythema	29.5% 59/200 • Number of events 87 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	27.0% 54/200 • Number of events 73 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
General disorders Pyrexia	44.0% 88/200 • Number of events 133 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	47.5% 95/200 • Number of events 137 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Infections and infestations Upper respiratory tract infection	23.0% 46/200 • Number of events 55 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	27.0% 54/200 • Number of events 69 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Infections and infestations Nasopharyngitis	3.5% 7/200 • Number of events 7 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	4.5% 9/200 • Number of events 10 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Infections and infestations Rhinitis	3.5% 7/200 • Number of events 8 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	3.5% 7/200 • Number of events 7 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
Infections and infestations Pneumonia	3.5% 7/200 • Number of events 7 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.	1.5% 3/200 • Number of events 3 • Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.

Additional Information

Medical Affairs Director

Crucell Switzerland AG

Phone: +41(0)319086111

Email: info@crucell.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any material for public dissemination will be submitted to the Sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee
• Publication restrictions are in place

Restriction type: OTHER