Vaccines are not required to undergo long term double blind inert placebo controlled trials to asses safety

Vaccines are tested rigorously right? What are they tested against? Interesting "placebo" choices...

(DTaP)

Daptacel tested against DTP and DT
https://www.vaccineshoppe.com/image.cfm…

Infanrix tested againt Pediarix. Both groups administered varying combinations of HepB, IPV, HIB, PCV, MMR & Varicella vaccines at the same time.
https://www.gsksource.com/…/Presc…/Infanrix/pdf/INFANRIX.PDF

Kinrix tested against Infanrix. Both groups also received IPV and MMR at same time.
https://www.gsksource.com/…/Prescribi…/Kinrix/pdf/KINRIX.PDF

Pediarix
German study: test group =Pediarix AND HIB versus control group = Infanrix, HIB AND OPV.
USA study: test group = Pediarix, HIB, PCV versus control group = Infanrix, Hep B, IPV, HIB, PCV
https://www.gsksource.com/…/Presc…/Pediarix/pdf/PEDIARIX.PDF

Pentacel (5 in 1: Dtap, Polio, HIB) tested against already licensed and non-licensed combinations of those vaccines. Both test and control groups also received PCV, HepB (and MMR at the last dose) at the same time.
https://www.vaccineshoppe.com/image.cfm…

Quadracel (4 in 1: Dtap & Polio) tested against already approved Daptacel & IPOL vaccines. Both test and control groups also received mmr and varicella vaccines at same time.
https://www.vaccineshoppe.com/image.cfm…

(HIB)

ActHIB reactions observed after administering ActHib or ActHib plus Daptacel, IPOL & PCV. No group did not get ActHib at all.
https://www.vaccineshoppe.com/image.cfm…

Hiberix tested against previously licensed HIB vaccines and both groups given various combinations of pediarix, PCV, rotarix & HepB at the same time. https://www.gsksource.com/…/Prescri…/Hiberix/pdf/HIBERIX.PDF

MenHibrix (Meningococcal & HIB) tested against a single licensed HIB vaccine. Both groups given various combinations of Pediarix, PCV, MMR or Varicella vaccines at the same time. https://gsksource.com/…/Prescri…/Menhibrix/pdf/MENHIBRIX.PDF

PedVaxHib (Meningococcal & HIB) tested against another form of pedvaxhib or a placebo. All groups given DTP and OPV at the same time. http://www.merck.com/…/pi_circul…/p/pedvax_hib/pedvax_pi.pdf

(Hep A)

Havrix - all groups received Havrix. Group 1: Havrix Group, 2: Havrix and MMR, Group 3 Havrix and Varicella.
https://www.gsksource.com/…/Prescribi…/Havrix/pdf/HAVRIX.PDF

TwinRix (Hep A & HepB tested against already approved Hep & and B vaccines given separately (Havrix & Engerix-B).
https://gsksource.com/…/Prescribing…/Twinrix/pdf/TWINRIX.PDF

(HepB)

Engerix-B given to all test subjects and observed for reactions. No control group was observed or compared.
https://www.gsksource.com/…/Pre…/Engerix-B/pdf/ENGERIX-B.PDF

Recombivax given to all test subjects. Infants and adults simply observed for reactions. Children compared the 2 vs 3 dose schedule.
http://www.merck.com/…/pi…/r/recombivax_hb/recombivax_pi.pdf

(HPV)

Gardasil tested against aluminum adjuvant or a "saline placebo". However, the saline placebo is made up of: water, 9.56mg sodium chloride, 0.78mg L-histidine and 50micrograms polysorbate-80.
http://www.merck.com/…/pi_circul…/g/gardasil/gardasil_pi.pdf

Gardasil 9 tested against regular Gardasil.
https://www.merck.com/…/pi_c…/g/gardasil_9/gardasil_9_pi.pdf

(Flu)

All flu vaccines observed for reactions, no control group, and/or against other flu vaccines.
http://www.immunize.org/fda/#flu

(MMR)

MMRII, adverse event observation of those who receive MMR.
http://www.merck.com/…/…/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf

ProQuad (mmr+varicela) tested against MMRII + Varivax given together.
http://www.merck.com/…/pi_circulars/p/proquad/proquad_pi.pdf

(Meningococcal ACWY)

Menactra tested against Menomune OR a group receiving PCV, MMRV and HepA instead.
https://www.vaccineshoppe.com/image.cfm…

Menomune was tested against Menactra.
https://www.vaccineshoppe.com/image.cfm…

Menvo was tested against groups getting typical childhood vaccines or a compararative vaccine.
https://gsksource.com/…/Prescribing_I…/Menveo/pdf/MENVEO.PDF

(Meningococcal)

Bexsero tested against either a meningococcal ACWY vaccine, Japanese encephalitis vaccine or an aluminum placebo.
https://gsksource.com/…/Prescribing…/Bexsero/pdf/BEXSERO.PDF

Trumenba tested against groups getting other vaccines and/or a "saline placebo". However, the saline placebo is made up of: water, 9.56mg sodium chloride, 0.78mg L-histidine and 50 micrograms polysorbate-80.
http://labeling.pfizer.com/ShowLabeling.aspx…

(Pneumococcal (PCV13)

Prevnar 13 tested against the old prevnar:
http://labeling.pfizer.com/showlabeling.aspx?id=501

(Polio)

IPOL (Inactivated Polio) tested by observing subjects who got IPOL, DTP & Tripedia vaccines at same time.
https://www.vaccineshoppe.com/image.cfm…

(Tdap)

Adacel tested against Td vaccine.
https://www.vaccineshoppe.com/image.cfm…

Boostrix tested against Td vaccine. Some participants also received meningococcal or flu vaccines at the same time.
https://gsksource.com/…/Prescribi…/Boostrix/pdf/BOOSTRIX.PDF

(Td)

TD Generic- states "Data on adverse reactions following fluid and adsorbed preparations of MassBiologics’ Td with various doses of the diphtheria and tetanus components have been reported in a series of studies." and also that it can be used to complete the dtap series but safety and efficacy has not been evaluated. Does not list study results.
https://www.fda.gov/…/Vaccin…/ApprovedProducts/UCM164127.pdf

Tennivac tested against a vaccine called Decavac.
https://www.vaccineshoppe.com/image.cfm…

(Varicella)

Varivax claims placebo based trials and later in the insert states no placebo based trials took place. Then describes trials with varying dosages of antigens and dosing schedules.
http://www.merck.com/…/pi_circulars/v/varivax/varivax_pi.pdf

*Rotavirus and Pneumovax actually claim placebo studies but the contents of their placebo were undetermined.

Info from Chris Kirckof