Clinical Trial Results:
A randomised controlled trial comparing two pertussis-containing vaccines in pregnancy and vaccine responses in UK mothers and their infants (immunising Mums Against Pertussis, iMAP2)
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Summary
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EudraCT number |
2013-004495-34 |
Trial protocol |
GB |
Global end of trial date |
30 Jun 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Feb 2019
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First version publication date |
02 Feb 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
iMAP2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02145624 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Eudract: 2013-004495-34 | ||
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Sponsors
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Sponsor organisation name |
Public Health England
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Sponsor organisation address |
Wellington House , London , United Kingdom, SE1 8UG
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Public contact |
Elizabeth Coates
elizabeth.coates@phe.gov.uk, Public Health England
Wellington House, London SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
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Scientific contact |
Elizabeth Coates
elizabeth.coates@phe.gov.uk, Public Health England
Wellington House, London SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Jun 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Jun 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jun 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Technical version - To compare anti-Pertussis Toxin (PT) IgG responses following primary immunisation with an acellular pertussis- containing vaccine in infants born to mothers who received REPEVAX in pregnancy compared to infants whose mothers received BOOSTRIX-IPV in pregnancy.
Lay version - to compare the amount of antibody against a particular part of the whooping cough vaccine in babies born to mothers given either Repevax or Boostrix-IPV whilst they were pregnant.
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Protection of trial subjects |
Fieldwork undertaken by specialised vaccine research nurses trained in paediatric venepuncture techniques. participants who were consented to provide blood samples were offered local anaesthetic cream prior to venepuncture
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 154
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Worldwide total number of subjects |
154
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EEA total number of subjects |
154
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
154
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
154 pregnant women randomised to receive 1 of two TdaP/IPV booster vaccines in the third trimester plus a control group of pregnant women who elected not to receive vaccine in pregnancy | |||||||||
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Pre-assignment
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Screening details |
• Bleeding disorder ,Received immunoglobulin or other blood product within the preceding 3 months ,Fulfil any of the contraindications to vaccination specified in The Green Book on Immunisation, including: A confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine , A confirmed anaphyl | |||||||||
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Period 1
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Period 1 title |
Period 1 (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
NOT BLINDED
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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ARM1 | |||||||||
Arm description |
Randomised to receive Repevax | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Repevax
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5ml
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Arm title
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ARM2 | |||||||||
Arm description |
Randomised to receive IPV-Boostrix | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
IPV-Boostrix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5ml
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Baseline characteristics reporting groups
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Reporting group title |
ARM1
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Reporting group description |
Randomised to receive Repevax | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ARM2
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Reporting group description |
Randomised to receive IPV-Boostrix | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ARM1
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Reporting group description |
Randomised to receive Repevax | ||
Reporting group title |
ARM2
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Reporting group description |
Randomised to receive IPV-Boostrix | ||
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End point title |
Primary Immunological | ||||||||||||
End point description |
The geometric mean titres to Pertussis toxin in infants after primary immunisation to 4 pertussis antigens in infants of mothers who received repevax versus those who received Boostrix-IPV
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End point type |
Primary
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End point timeframe |
3 to 6 weeks after vaccination
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Statistical analysis title |
Pre Planned Analysis | ||||||||||||
Statistical analysis description |
Comparison of GMTs in infants and mothers by vaccine group at different time points
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Comparison groups |
ARM1 v ARM2
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Number of subjects included in analysis |
127
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
< 5 | ||||||||||||
Method |
Kruskal-wallis | ||||||||||||
Confidence interval |
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| Notes [1] - . Geometric mean titres, concentrations and fold differences, as well as proportions above thresholds will also be calculated with 95% confidence intervals. |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Vaccination to last visit for blood sampling at 3-6 weeks post vaccination
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Adverse event reporting additional description |
All SAEs will be reported to relevant research governance requirements
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
ARM1
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Reporting group description |
Mothers receiving Repevax | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ARM2
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Reporting group description |
Mothers receiving Boostrix | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: None systematically collected. only SAEs collected in this study |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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14 Aug 2014 |
Correction of column headings in treatment table(section 6.2)
Amendment of first infant blood sample, to be collected from 0-7 days
Addition of polio testing in main protocol and appendices, as well as actions for extra vaccine doses on low antibody results
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08 Jul 2015 |
Addition of Bexsero (Meningococcal group B vaccine) to vaccine schedule as per UK national immunisation schedule. Inclusion of possible testing of Men B responses if sufficient sera and funding |
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11 Jan 2016 |
Inclusion of option for home visits for vaccination as well as sample collection on p.28 |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
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