| CTRI Number |
CTRI/2014/11/005207 [Registered on: 18/11/2014] Trial Registered Retrospectively |
| Last Modified On: |
13/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relationship of order of vaccination with associated pain in infant |
|
Scientific Title of Study
|
Comparison of antinociceptive effect of order of whole cell DTP and Hepatitis B vaccine in less than 4 months healthy infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIT UPADHYAY |
| Designation |
Associate Professor and Head of Department of Pediatrics |
| Affiliation |
L.L.R.M COLLEGE,MEERUT |
| Address |
DEPARTMENT OF PEDIATRICS,L.L.R.M MEDICAL
COLLEGE,MEERUT
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837405009 |
| Fax |
01212760888 |
| Email |
anuamit7@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMIT UPADHYAY |
| Designation |
Associate Professor and Head of Department of Pediatrics |
| Affiliation |
L.L.R.M COLLEGE,MEERUT |
| Address |
DEPARTMENT OF PEDIATRICS,L.L.R.M MEDICAL
COLLEGE,MEERUT
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837405009 |
| Fax |
01212760888 |
| Email |
anuamit7@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MITHILESH KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
LLRM Medical college, Meerut |
| Address |
DEPARTMENT OF PEDIATRICS,L.L.R.M MEDICAL
COLLEGE,MEERUT
UTTAR PRADESH
250004
India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
87557603655 |
| Fax |
|
| Email |
drmith2010@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
N/A |
| Type of Sponsor |
Other [none] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AMIT UPADHYAY |
Immunisation clinic,Pediatric outpatient department |
Department of Pediatrics ,
LLRM Medical College,
Meerut-250004
Meerut
UTTAR PRADESH |
9837405009
01212760888
anuamit7@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Com mittee(IEC),L.L.R.M Medical college,Meerut |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy term infants less than 4 months of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DTwP vaccine injection first followed by Hepatitis B vaccine injection |
0.5 ml of DTwP vaccine( Abhay-TAG) was administered intramuscular at anterolateral aspect of one thigh by 0.6 x 25 mm( 23 gauge ) needle . one minute later it was followed by administration of Hepatitis B vaccine (manufactured by biological E. limited) on other thigh at anterolateral aspect with 0.6 x 25 mm( 23 gauge ) needle |
| Intervention |
hepatitis B vaccine injection first followed by DTwP vaccine injection |
0.5 ml of hepatitis B vaccine (manufactured by biological E. limited) was administered intramuscular at anterolateral aspect of one thigh by 0.6 x 25 mm( 23 gauge ) needle . one minute later it was followed by administration of DTwP( Abhay-TAG) vaccine on other thigh at anterolateral aspect with 0.6 x 25 mm( 23 gauge ) needle |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
4.00 Month(s) |
| Gender |
Both |
| Details |
Full term healthy infants, less than four months of postnatal age, who attend immunization clinic for first wDPT vaccine according to universal immunization program |
|
| ExclusionCriteria |
| Details |
• All infants who have required hospital admission more than 48 hrs.
• Perinatal asphyxia (1 min Apgar Score <7) or delayed cry if born at home.
• Intra-uterine growth retardation (IUGR) i.e. wt < 10th centile for gestational age
• Pre-term deliveries. (< 37 week of gestation )
• Previous surgery
• Any congenital anomaly
• Any chronic medical conditions,
• Allergy to any of the vaccine components
• Concurrently receiving topical local anaesthetics
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome was infant pain. Infant pain assessment was done by Modified facial coding System (MFCS) and Neonatal infant pain scale (NIPS) |
Pain score (MFCS and NIPS) were assessed prior to first vaccination, immediately after first vaccination, at 20-30 seconds after first vaccination, prior to second vaccination,immediately after second vaccination at 20-30 seconds after 2nd vaccination and at one minute after second vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome was heart rate ,saturation of oxygen(SPO2), and duration of cry |
Heart rate and SPO2 was assessed prior to,within 20-30 seconds of administration of both vaccine injection with TruscopeII multi utility Patient monitor(by Schiller).Duration of cry was assessed after first and second vaccine injection as first cry duration( maximum upto one minute after vaccine injection ),second cry duration (maximum upto 3 minutes after vaccine injection) respectively . Additionally total cry duration was calculated by adding first and second cry duration. |
|
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Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/11/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="22" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a Single-center, randomized, parallel group, active controlled trial to determine if acute pain response after administration of the DTwP vaccine and the Hepatitis-B vaccine is affected by the order in which they are given. Setting: This study is carried out in the immunization clinic, Department of Paediatrics, LLRM Medical College , Meerut, India.Participants-Full term healthy infants, less than four months of postnatal age, who attend immunization clinic for first wDPT vaccine according to universal immunization program. Intervention- infant received either DTwP or Hepatitis B vaccine followed one minute later by other vaccine ..The primary outcome measure was infant pain, which was assessed by Modified facial coding system and Neonatal infant pain scale from the videotapes by a research assistant blinded to the study hypothesis. In addition heart rate , SPO2 was assessed prior to, within 20-30 sec of both vaccine injection . Duration of cry was also assessed as first cry duration ( maximum upto one minute ), second cry duration (maximum upto 3 min after second vaccine injection) and total cry duration ( adding the first and second cry duration)
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