The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
NCT Number: NCT00390130
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.
Looking for future studies?
Notify Me2 month–6 month
All sexes
Interventional
Phase 4
Toronto, Ontario, M5G 1X8, Canada
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 (DPTaP+Hib) 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Immediately after vaccination
The Hospital for Sick Children
Other
Does the Order in Which Vaccines Are Administered Affect Pain Response? A Randomized, Double-blind, Clinical Trial of Pentacel vs. Prevnar
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details