Trial Outcomes & Findings for A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine (NCT NCT02692859)

NCT ID: NCT02692859

Last Updated: 2017-09-20

Results Overview

Number of Participants with Solicited Adverse Reactions

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1992 participants
• Primary outcome timeframe: 0-7 days after each dose
• Results posted on: 2017-09-20

Participant Flow

Participant milestones

Measure	Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose	Vaccine (Walvax Biotechnology Co., LTD.) Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose
Overall Study STARTED	996	996
Overall Study COMPLETED	912	901
Overall Study NOT COMPLETED	84	95

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine

Baseline characteristics by cohort

Measure	Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) n=996 Participants Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose	Vaccine (Walvax Biotechnology Co., LTD.) n=996 Participants Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose	Total n=1992 Participants Total of all reporting groups
Age, Categorical <=18 years	996 Participants n=5 Participants	996 Participants n=7 Participants	1992 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 12-60 months	38.52 months STANDARD_DEVIATION 12.84 • n=5 Participants	37.32 months STANDARD_DEVIATION 13.92 • n=7 Participants	37.92 months STANDARD_DEVIATION 13.44 • n=5 Participants
Age, Continuous 6-11 months	8.31 months STANDARD_DEVIATION 1.80 • n=5 Participants	8.20 months STANDARD_DEVIATION 1.80 • n=7 Participants	8.26 months STANDARD_DEVIATION 1.80 • n=5 Participants
Age, Continuous 3-5 months	4.26 months STANDARD_DEVIATION 0.82 • n=5 Participants	4.27 months STANDARD_DEVIATION 0.83 • n=7 Participants	4.27 months STANDARD_DEVIATION 0.83 • n=5 Participants
Sex: Female, Male Female	481 Participants n=5 Participants	464 Participants n=7 Participants	945 Participants n=5 Participants
Sex: Female, Male Male	515 Participants n=5 Participants	532 Participants n=7 Participants	1047 Participants n=5 Participants
Region of Enrollment China	996 participants n=5 Participants	996 participants n=7 Participants	1992 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-7 days after each dose

Population: A total of participants in aged 3-5 months,6-11months and 1-5years

Number of Participants with Solicited Adverse Reactions

Outcome measures

Measure	Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) n=996 Participants Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose	Vaccine (Walvax Biotechnology Co., LTD.) n=996 Participants Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose
Number of Participants With Solicited Adverse Reactions	507 Count of Participants	480 Count of Participants

PRIMARY outcome

Timeframe: 28 days after full course of vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-28 days after each dose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after full course of vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after full course of vaccination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after full course of vaccination

Outcome measures

Outcome data not reported

Adverse Events

Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaccine (Walvax Biotechnology Co., LTD.)

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) n=996 participants at risk Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose	Vaccine (Walvax Biotechnology Co., LTD.) n=996 participants at risk Hib conjugate vaccine Hib conjugate vaccine: Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 y:one dose(0 d), 0.5ml for each dose
Infections and infestations bronchopneumonia	0.60% 6/996 • Number of events 6	1.2% 12/996 • Number of events 12
Infections and infestations upper respiratory tract infection	0.10% 1/996 • Number of events 1	0.00% 0/996
Gastrointestinal disorders hand-foot-and-mouth disease	0.10% 1/996 • Number of events 1	0.10% 1/996 • Number of events 1
Infections and infestations pneumonia	0.10% 1/996 • Number of events 1	0.10% 1/996 • Number of events 1
Gastrointestinal disorders viral enteritis	0.10% 1/996 • Number of events 1	0.10% 1/996 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Kai Chu

jiangsuPCDCP

Phone: 18915999781

Email: chukai19812007@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place