Trial Outcomes & Findings for Phase III Study of Intramuscular TAK-816 in Healthy Infants (NCT NCT02074345)
NCT ID: NCT02074345
Last Updated: 2016-04-26
Results Overview
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
For 64 Weeks
Results posted on
2016-04-26
Participant Flow
Participants took part in the study at 4 investigative sites in Japan from 13 March 2014 to 25 March 2015.
Participants received open-label TAK-816 0.5 mL vaccinations, 3 initial doses and 1 booster.
Participant milestones
| Measure |
TAK-816 0.5 mL
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
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Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Study of Intramuscular TAK-816 in Healthy Infants
Baseline characteristics by cohort
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
|
Age, Continuous
|
2.54 months
STANDARD_DEVIATION 0.587 • n=5 Participants
|
|
Age, Customized
<2 months
|
0 participants
n=5 Participants
|
|
Age, Customized
≥2 - <3 months
|
22 participants
n=5 Participants
|
|
Age, Customized
≥3 - <4 months
|
8 participants
n=5 Participants
|
|
Age, Customized
≥4 - <5 months
|
1 participants
n=5 Participants
|
|
Age, Customized
≥5 months
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
31 participants
n=5 Participants
|
|
Height
|
58.2 cm
STANDARD_DEVIATION 2.38 • n=5 Participants
|
|
Weight
|
5.62 kg
STANDARD_DEVIATION 0.551 • n=5 Participants
|
|
Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer Before Primary Immunization
<0.15 µg/mL
|
4 participants
n=5 Participants
|
|
Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer Before Primary Immunization
≥0.15 µg/mL
|
27 participants
n=5 Participants
|
|
Simultaneous Vaccination of Pneumococcal Vaccine
Yes
|
0 participants
n=5 Participants
|
|
Simultaneous Vaccination of Pneumococcal Vaccine
No
|
31 participants
n=5 Participants
|
|
Simultaneous Vaccination of Diphtheria, Tetanus, Pertussis-Inactivated Polio Vaccine (DPT-IPV)
Yes
|
0 participants
n=5 Participants
|
|
Simultaneous Vaccination of Diphtheria, Tetanus, Pertussis-Inactivated Polio Vaccine (DPT-IPV)
No
|
31 participants
n=5 Participants
|
|
Simultaneous Vaccination of Rotavirus Vaccine
Yes
|
27 participants
n=5 Participants
|
|
Simultaneous Vaccination of Rotavirus Vaccine
No
|
4 participants
n=5 Participants
|
|
Simultaneous Vaccination of Measles-Rubella (MR) Vaccine
Yes
|
0 participants
n=5 Participants
|
|
Simultaneous Vaccination of Measles-Rubella (MR) Vaccine
No
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For 64 WeeksPopulation: Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination.
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
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Number of Participants With Adverse Events
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31 participants
|
PRIMARY outcome
Timeframe: For 64 WeeksPopulation: FAS included all participants who received at least 1 dose of the study vaccination.
Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
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Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)
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6 participants
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PRIMARY outcome
Timeframe: For 64 WeeksPopulation: FAS included all participants who received at least 1 dose of the study vaccination.
Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
|
|---|---|
|
Number of Participants With Adverse Reactions Related to Local Reactions
Injection site erythema
|
5 participants
|
|
Number of Participants With Adverse Reactions Related to Local Reactions
Injection site swelling
|
1 participants
|
|
Number of Participants With Adverse Reactions Related to Local Reactions
Injection site induration
|
1 participants
|
|
Number of Participants With Adverse Reactions Related to Local Reactions
Injection site pain
|
0 participants
|
PRIMARY outcome
Timeframe: For 64 WeeksPopulation: FAS included all participants who received at least 1 dose of the study vaccination.
Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
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Number of Participants With Adverse Reactions Related to Systemic Reactions
Rash
|
0 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Vomiting
|
1 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Diarrhoea
|
5 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Irritability
|
0 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Crying
|
3 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Decreased appetite
|
0 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Somnolence
|
3 participants
|
|
Number of Participants With Adverse Reactions Related to Systemic Reactions
Insomnia
|
2 participants
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SECONDARY outcome
Timeframe: For 64 weeksPopulation: FAS, all participants who received at least 1 dose of the study vaccination, with available data.
Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
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Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
Before Primary Immunization (n=31)
|
16.1 percentage of participants
Interval 5.452 to 33.727
|
|
Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
At 4 Weeks after Primary Immunization (n=30)
|
100 percentage of participants
Interval 88.43 to 100.0
|
|
Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
Before Booster Vaccination (n=31)
|
77.4 percentage of participants
Interval 58.904 to 90.406
|
|
Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
At 4 Weeks after Booster Vaccination (n=31)
|
100 percentage of participants
Interval 88.781 to 100.0
|
SECONDARY outcome
Timeframe: For 64 weeksPopulation: FAS, all participants who received at least 1 dose of the study vaccination, with available data.
Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
|
|---|---|
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Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
Before Primary Immunization (n=31)
|
87.1 percentage of participants
Interval 70.166 to 96.37
|
|
Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
At 4 Weeks after Primary Immunization (n=30)
|
100 percentage of participants
Interval 88.43 to 100.0
|
|
Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
Before Booster Vaccination (n=31)
|
100 percentage of participants
Interval 88.781 to 100.0
|
|
Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
At 4 Weeks after Booster Vaccination (n=31)
|
100 percentage of participants
Interval 88.781 to 100.0
|
SECONDARY outcome
Timeframe: For 64 weeksPopulation: FAS, all participants who received at least 1 dose of the study vaccination, with available data.
Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.
Outcome measures
| Measure |
TAK-816 0.5 mL
n=31 Participants
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
|
Geometric Mean Titer (GMT) of Anti-PRP Antibody
Before Primary Immunization (n=31)
|
0.354 μg/mL
Interval 0.2583 to 0.4843
|
|
Geometric Mean Titer (GMT) of Anti-PRP Antibody
At 4 Weeks after Primary Immunization (n=30)
|
19.682 μg/mL
Interval 11.3094 to 34.2544
|
|
Geometric Mean Titer (GMT) of Anti-PRP Antibody
Before Booster Vaccination (n=31)
|
3.087 μg/mL
Interval 2.0482 to 4.6518
|
|
Geometric Mean Titer (GMT) of Anti-PRP Antibody
At 4 Weeks after Booster Vaccination (n=31)
|
51.334 μg/mL
Interval 31.0689 to 84.8159
|
Adverse Events
TAK-816 0.5 mL
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-816 0.5 mL
n=31 participants at risk
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
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Gastrointestinal disorders
Inguinal hernia
|
3.2%
1/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
3.2%
1/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
3.2%
1/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.2%
1/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
TAK-816 0.5 mL
n=31 participants at risk
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
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|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
35.5%
11/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
45.2%
14/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site erythema
|
16.1%
5/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Crying
|
12.9%
4/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site swelling
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
48.4%
15/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
12.9%
4/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
9.7%
3/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis bacterial
|
9.7%
3/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Exanthema subitum
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Molluscum contagiosum
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
9.7%
3/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.9%
4/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
16.1%
5/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
19.4%
6/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
9.7%
3/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
9.7%
3/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • For 64 weeks
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER