Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390130
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2006-10-17
Brief Title:
Does the Order in Which Vaccines Are Administered Affect Pain Response
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Does the Order in Which Vaccines Are Administered Affect Pain Response A Randomized Double-blind Clinical Trial of Pentacel vs Prevnar
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine whether there should be a predetermined sequence recommended for administering these two vaccines with the less painful vaccine being given first
Detailed Description:
Childhood vaccination is one of the most effective public health measures worldwide with few serious adverse effects reported However pain on vaccination continues to be a frequent occurrence and is the most common cause of childhood iatrogenic pain In a recent study of paediatricians in the USA more than ninety percent reported at least one parental vaccine refusal in the past year The most common concerns cited by parents were short-term reactions and pain from multiple injections
One of the factors responsible for vaccination pain is the vaccine material itself Even the same vaccine when made by different pharmaceutical companies may produce different pain responses Anecdotal reports from doctors and nurses indicate that Pentacel DPTaPHib is a relatively painless vaccine to administer whereas Prevnar conjugated pneumococcal vaccine causes significant pain on injection and severe distress to the infant being vaccinated For this reason many vaccinators administer Pentacel DPT prior to Prevnar PCV when providing both vaccines in one visit However the difference in infant pain responses has not been documented Although it has been shown that very early pain events affect infants later experience of pain it has not been demonstrated that the sequence in which vaccines are administered affects pain response This study will assess whether there should be a predetermined sequence recommended for administering these two vaccines with the less painful vaccine Pentacel being given first
One of the factors responsible for vaccination pain is the vaccine material itself Even the same vaccine when made by different pharmaceutical companies may produce different pain responses Anecdotal reports from doctors and nurses indicate that Pentacel DPTaPHib is a relatively painless vaccine to administer whereas Prevnar conjugated pneumococcal vaccine causes significant pain on injection and severe distress to the infant being vaccinated For this reason many vaccinators administer Pentacel DPT prior to Prevnar PCV when providing both vaccines in one visit However the difference in infant pain responses has not been documented Although it has been shown that very early pain events affect infants later experience of pain it has not been demonstrated that the sequence in which vaccines are administered affects pain response This study will assess whether there should be a predetermined sequence recommended for administering these two vaccines with the less painful vaccine Pentacel being given first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None