Trial Outcomes & Findings for Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants (NCT NCT00798304)
NCT ID: NCT00798304
Last Updated: 2014-11-26
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
1 month after Dose 3
Results posted on
2014-11-26
Participant Flow
In this study, participants were to receive recombinant lipoprotein 2086 (rLP2086) vaccine at 2, 4, 6 and 12 months of age. Due to premature termination of study, only single dose of 20 or 60 microgram (mcg) of rLP2086 vaccine was administered at 2 months and planned treatments of rLP2086 vaccine 120 mcg and 200 mcg were not administered.
Participant milestones
| Measure |
Control
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
|
rLP2086 20 mcg
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
|
rLP2086 60 mcg
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
22
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
22
|
10
|
Reasons for withdrawal
| Measure |
Control
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
|
rLP2086 20 mcg
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
|
rLP2086 60 mcg
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Discontinuation by Sponsor
|
14
|
21
|
9
|
Baseline Characteristics
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Baseline characteristics by cohort
| Measure |
Control
n=14 Participants
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
|
rLP2086 20 mcg
n=22 Participants
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
|
rLP2086 60 mcg
n=10 Participants
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.6 days
STANDARD_DEVIATION 11.57 • n=5 Participants
|
64.0 days
STANDARD_DEVIATION 10.02 • n=7 Participants
|
71.6 days
STANDARD_DEVIATION 11.35 • n=5 Participants
|
65.5 days
STANDARD_DEVIATION 11.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 month after Dose 3Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From signing of informed consent form to completion of study (up to 2 years)Outcome measures
| Measure |
Control
n=14 Participants
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
|
rLP2086 20 mcg
n=22 Participants
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
|
rLP2086 60 mcg
n=10 Participants
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE)
|
21.4 percentage of participants
|
31.8 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 month after Dose 2, Dose 3; before Dose 4Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month after Dose 2, Dose 3; before Dose 4Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4Population: Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
rLP2086 20 mcg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
rLP2086 60 mcg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=14 participants at risk
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
|
rLP2086 20 mcg
n=22 participants at risk
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
|
rLP2086 60 mcg
n=10 participants at risk
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
10.0%
1/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Injury, poisoning and procedural complications
Respiratory syncytial virus bronchiolitis
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
9.1%
2/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
Other adverse events
| Measure |
Control
n=14 participants at risk
Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
|
rLP2086 20 mcg
n=22 participants at risk
Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
|
rLP2086 60 mcg
n=10 participants at risk
rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
7.1%
1/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
10.0%
1/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
10.0%
1/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
1/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Respiratory tract infection viral
|
7.1%
1/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.1%
1/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
4.5%
1/22 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
0.00%
0/10 • AEs/SAEs: recorded from signing of informed consent form to completion of study (up to 2 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER